Quinton, Inc.
Bothell, WA, US
Quinton, Inc. appears in FDA device records in Bothell, WA. FDA records list 164 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 164
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 164FDA records hold 164 510(k) clearances for Quinton, Inc. between 1976 and 2003. The busiest year on record is 1987, with 22. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 12 |
| 1978 | 9 |
| 1979 | 5 |
| 1980 | 3 |
| 1981 | 12 |
| 1982 | 10 |
| 1983 | 11 |
| 1984 | 13 |
| 1985 | 9 |
| 1986 | 13 |
| 1987 | 22 |
| 1988 | 10 |
| 1989 | 13 |
| 1990 | 3 |
| 1991 | 4 |
| 1992 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | DQK | Substantially Equivalent | |
| K021906 | QUINTON Q-CATH, MODEL 000460 | DQK | Substantially Equivalent | |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | DSI | Substantially Equivalent | |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | DPS | Substantially Equivalent | |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | DSI | Substantially Equivalent | |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | ISD | Substantially Equivalent | |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | ITX | Substantially Equivalent | |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | DPS | Substantially Equivalent | |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | DQA | Substantially Equivalent | |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | MPB | Substantially Equivalent | |
| K961014 | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K945626 | QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K943349 | MAHURKAR DUAL LUMEN CATHETER | FOZ | Unknown | |
| K922254 | LUKENS 2-0 BRAIDED SILK SUTURES | DQO | Substantially Equivalent | |
| K910017 | Q4500 STREE TEST MONITOR | DPS | Substantially Equivalent | |
| K912227 | MONARK ERGOMETERS | ISD | Substantially Equivalent | |
| K910808 | Q-SMART HOLTER SYSTEMS | DSI | Substantially Equivalent | |
| K911751 | MEDTRACK TREADMILL | IOL | Substantially Equivalent | |
| K900835 | MODIFIED PERM-CATH | LFJ | Substantially Equivalent | |
| K894650 | Q-PORT SYSTEM KIT | LJT | Substantially Equivalent | |
| K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER | MPB | Substantially Equivalent | |
| K895779 | MODIFIED PERMCATH TRAY (2ND SUBMISSION) | CBK | Substantially Equivalent | |
| K895440 | QUINTON MAHURKAR CATHETERS W/VITACUFF | DQY | Substantially Equivalent | |
| K892450 | MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS | KGX | Substantially Equivalent | |
| K893909 | MODIFIED MATERIAL USED IN INFUSION T | FPA | Substantially Equivalent | |
| K893420 | MASTERLAB PFT AND MASTERLAB BODY BOX | CCM | Substantially Equivalent | |
| K893188 | QUINTON SINGLE LUMEN CATHETER | MPB | Substantially Equivalent | |
| K892113 | Q5000 PC WORKSTATION | DQK | Substantially Equivalent | |
| K881235 | Q-PLEX 1 | BZC | Substantially Equivalent | |
| K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | FJS | Substantially Equivalent | |
| K885000 | Q750 ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K885188 | MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY | DWF | Substantially Equivalent | |
| K884102 | MODIFIED 7 INCH CONTINUOUS INFUSION SETS | FPA | Substantially Equivalent | |
| K883402 | EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER) | DPS | Substantially Equivalent | |
| K885062 | MODIFIED Q-SERIES OF TREADMILLS | IOL | Substantially Equivalent | |
| K883468 | Q5000 ST/HR SLOPE MODIFICATION | DPS | Substantially Equivalent | |
| K882978 | Q4000 OPTION FOR Q4000 | DSI | Substantially Equivalent | |
| K883009 | NON-CORING NEEDLES | FMI | Substantially Equivalent | |
| K883031 | Q-CATH RM | DXJ | Substantially Equivalent | |
| K882097 | TUNNELING STYLET | DRB | Substantially Equivalent | |
| K881352 | RIGHT ATRIAL CATHETER INSERTION TRAY | DWF | Substantially Equivalent | |
| K880583 | MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH | MPB | Substantially Equivalent | |
| K874633 | PERMCATH INSERTION TRAY | LFJ | Unknown | |
| K880271 | RESUBMITTED EXCALIBUR | ISD | Substantially Equivalent | |
| K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT | FKX | Substantially Equivalent | |
| K874403 | A SERIES OF 7 INCH CONTINUOUS INFUSION SETS | FPA | Substantially Equivalent | |
| K874650 | PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) | FKO | Substantially Equivalent | |
| K873584 | MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR | DPS | Substantially Equivalent | |
| K873727 | PULL-APART INTRODUCER (SHEATH) | DYB | Substantially Equivalent | |
| K873394 | OVAL PULL-APART SHEATH/DILATOR | DYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNZAccessories, A-V Shunt
- KOCAccessories, Blood Circuit, Hemodialysis
- KGZAccessories, Catheter
- GCEAdaptor, Catheter
- FKNAdaptor, Shunt
- IKDCable, Electrode
- BZCCalculator, Pulmonary Function Data
- FIQCannula, A-V Shunt
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- GBQCatheter, Continuous Irrigation
- LFKCatheter, Femoral
- MPBCatheter, Hemodialysis, Non-Implanted
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- FKOCatheter, Peritoneal Dialysis, Single Use
- FJSCatheter, Peritoneal, Long-Term Indwelling
- LFJCatheter, Subclavian
- FKCClamp, Cannula
- FFNClamp, Non-Electrical
- DQKComputer, Diagnostic, Programmable
- FKBConnector, Blood Tubing, Infusion T
- FJQConnector, Shunt
- FKYConnector, Tubing, Dialysate
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- DREDilator, Vessel, For Percutaneous Catheterization
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- ISDExerciser, Measuring
- KNWInstrument, Biopsy
- DYBIntroducer, Catheter
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- FMINeedle, Hypodermic, Single Lumen
- DQAOximeter
- CCMPlethysmograph, Pressure
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- JYZRod, Measuring Ear
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)
- DRBStylet, Catheter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- FKXSystem, Peritoneal, Automatic Delivery
- KXJTable, Radiologic
- KGXTape And Bandage, Adhesive
- FKWTip, Vessel
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- IOLTreadmill, Powered
- CBKVentilator, Continuous, Facility Use
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain