Parke-Davis Co.
Mchenry, IL, US
Parke-Davis Co. appears in FDA device records in Mchenry, IL. FDA records list 47 510(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
- 47
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 47 510(k) clearances for Parke-Davis Co. between 1976 and 1986. The busiest year on record is 1984, with 17. The most recent is 1986, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 8 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 17 |
| 1985 | 7 |
| 1986 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | FOZ | Substantially Equivalent | |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | DYG | Substantially Equivalent | |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | FRC | Substantially Equivalent | |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | KRA | Substantially Equivalent | |
| K860290 | VIAPIC CENTRAL LINE CATHETER | FOZ | Substantially Equivalent | |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | FRC | Substantially Equivalent | |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | DXG | Substantially Equivalent | |
| K851327 | DESERET ARTERIAL CATHETER | FOZ | Substantially Equivalent | |
| K852078 | SPECTRUM(TENTATIVE) | FOZ | Substantially Equivalent | |
| K844840 | DESERET INTRODUCER SET | DYB | Substantially Equivalent | |
| K850505 | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER | BSO | Substantially Equivalent | |
| K850439 | DESERET EPIDURAL CATHETER | BSO | Substantially Equivalent | |
| K843033 | DESERET INTRAVASCULAR CATHETER | FOZ | Substantially Equivalent | |
| K844219 | DESERET DENTRAL LINE CATHETER | FOZ | Substantially Equivalent | |
| K844113 | DESERET SUBCLAVIAN JUGULAR CATHETER SET | FOZ | Substantially Equivalent | |
| K841968 | DESERET DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | |
| K841317 | DESERET HEPARIN COATED FLOW DIRECTED | DYG | Substantially Equivalent | |
| K841251 | DESERET HEPARIN COATED FLOW CATH | DYG | Substantially Equivalent | |
| K841168 | STERILIZATION PROCESS INDICATOR | JOJ | Substantially Equivalent | |
| K840958 | DESERET LONG TERM INDWELLING CATHETER | LJS | Substantially Equivalent | |
| K840116 | DESERET INFANT CENTRAL VENOUS CATHE- | FOZ | Substantially Equivalent | |
| K840862 | DESERET CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K840355 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR | FOZ | Substantially Equivalent | |
| K840183 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR | FOZ | Substantially Equivalent | |
| K834227 | DESERET SUBCLAVIAN JUGULAR CATH. SET | FOZ | Substantially Equivalent | |
| K834393 | DESERET NEONATAL CATHETER SET | FOZ | Substantially Equivalent | |
| K833976 | VANISH | KGO | Substantially Equivalent | |
| K834472 | DESERET EPIDURAL CATHETER | Substantially Equivalent | ||
| K832352 | 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE | BSO | Substantially Equivalent | |
| K833135 | INTRACATH INTRAVENOUS CATHETER UNIT | FOZ | Substantially Equivalent | |
| K832058 | ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. | KRA | Substantially Equivalent | |
| K823064 | INTRACATH-DA INTRAVENOUS CATH. PLACEMENT | DQO | Substantially Equivalent | |
| K823086 | DESERET SURGEON'S GLOVE ACCESSORY | KGO | Substantially Equivalent | |
| K823065 | INTRA CATH-DSA INTRAVENOUS CATH PLACE. | DQO | Substantially Equivalent | |
| K823066 | DESERT INSYTE-A HYPERTHERMIA SENSOR ACC | FLL | Substantially Equivalent | |
| K782148 | HR UNIT | IQP | Substantially Equivalent | |
| K781031 | AEROPLAST DRESSING | KMF | Substantially Equivalent | |
| K771036 | SHAVE PREP TRAY | KKX | Substantially Equivalent | |
| K770466 | STOCKINGS, RVS TM | EQL | Substantially Equivalent | |
| K761035 | SURGICAL BLADE HANDLES | GDZ | Substantially Equivalent | |
| K760924 | TUCKS POLYPAD MATERNITY CARE PAD | HHD | Substantially Equivalent | |
| K760817 | ORTHOPEDIC TUBULAR STOCKINETTE | ILG | Substantially Equivalent | |
| K760578 | BALANCED CAST SOLE | IPG | Substantially Equivalent | |
| K760342 | RAZOR, SCHICK DISPOSABLE | LDQ | Substantially Equivalent | |
| K760164 | UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) | EYQ | Substantially Equivalent | |
| K760016 | SURGICAL BLADES (BEAVER) | Substantially Equivalent | ||
| K760113 | SPONGE, LAPAROTOMY GAUZE | EFQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KMFBandage, Liquid
- BSOCatheter, Conduction, Anesthetic
- KRACatheter, Continuous Flush
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- KKXDrape, Surgical, Antimicrobial
- EYQGarment, Protective, For Incontinence
- EFQGauze/Sponge, Internal
- GDZHandle, Scalpel
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- DYBIntroducer, Catheter
- EQLLaryngostroboscope
- HHDPad, Menstrual, Unscented
- IQPRotator, Transverse
- IPGShoe, Cast
- ILGStocking, Elastic
- KGOSurgeon'S Gloves
- DRSTransducer, Blood-Pressure, Extravascular
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