Dlp, Inc.
Grand Rapids, MI, US
Dlp, Inc. appears in FDA device records in Grand Rapids, MI. FDA records list 39 510(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
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Dlp, Inc. between 1984 and 1997. The busiest year on record is 1985, with 6. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 6 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973485 | CLEARVIEW BLOWER/MISTER | FQH | Substantially Equivalent | |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | DWS | Substantially Equivalent | |
| K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | DWF | Substantially Equivalent | |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | GCY | Substantially Equivalent | |
| K934215 | CONTAIN-OR | KKX | Substantially Equivalent | |
| K915268 | CATHETER TWO STAGE VENOUS RETURN | DWF | Substantially Equivalent | |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | GAA | Substantially Equivalent | |
| K913077 | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | DTR | Substantially Equivalent | |
| K913098 | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 | KNW | Substantially Equivalent | |
| K912229 | IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 | GEI | Substantially Equivalent | |
| K904172 | ACCUPLACE (TM) | GDF | Substantially Equivalent | |
| K900994 | ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. | DTL | Substantially Equivalent | |
| K901074 | CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA | DWF | Substantially Equivalent | |
| K900082 | MAXX 470 CORE BIOPSY GUN | KNW | Substantially Equivalent | |
| K897022 | PICSO CANNULA, CATALOG CODE 94315 | DWF | Substantially Equivalent | |
| K896019 | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. | GAA | Substantially Equivalent | |
| K893418 | MYOCARDIAL PROBE THERMOMETER CODE 64000 | FLL | Substantially Equivalent | |
| K891537 | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | GDM | Substantially Equivalent | |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | DWS | Substantially Equivalent | |
| K890453 | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | DWZ | Substantially Equivalent | |
| K880860 | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 | DQT | Substantially Equivalent | |
| K880421 | DESCENDING ARCH CANNULA | DWF | Substantially Equivalent | |
| K875353 | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT | DWF | Substantially Equivalent | |
| K871137 | MINISTIK MINI PUNCTURE SET CATALOG CODE #57505 | DQX | Substantially Equivalent | |
| K865079 | ASPIRATING NEEDLE, CATALOG CODE #12006 | DWF | Substantially Equivalent | |
| K864329 | MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT | KNW | Substantially Equivalent | |
| K860149 | VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 | DWF | Substantially Equivalent | |
| K855089 | PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505 | DQX | Substantially Equivalent | |
| K854487 | VENOUS RETURN CANNULA W/CUFF 91039 | DWF | Substantially Equivalent | |
| K855144 | TOURIQUET KIT WITH SNARE | GDJ | Substantially Equivalent | |
| K853586 | PRESSURE SENSING SYRINGE 65000 | DTL | Substantially Equivalent | |
| K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | DXS | Substantially Equivalent | |
| K852184 | ELECTRO-CAUTERY KNIFE CLEANER 6000 1 | HAM | Substantially Equivalent | |
| K850385 | INTRACARDIAC SUMP 12010 | DWF | Substantially Equivalent | |
| K845046 | PUL,MONARY ARTERY VENT CATHETER | DWF | Substantially Equivalent | |
| K845045 | VENOUS RETURN CATHETER SS-1 | DWF | Substantially Equivalent | |
| K840002 | ARTERIAL CANNULA CURVED BEVELED TIP | DWF | Substantially Equivalent | |
| K840001 | ARTERIAL CANNULA STRAIGHT BEVELED TIP | DWF | Substantially Equivalent | |
| K834039 | INFANT VENT CATHETER 12001 W/SIDE VENT | DWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- HAMApparatus, Electrosurgical
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- GDJClamp, Surgical, General & Plastic Surgery
- FLLContinuous Measurement Thermometer
- DWZDevice, Biopsy, Endomyocardial
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- GDFGuide, Needle, Surgical
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- KNWInstrument, Biopsy
- DWSInstruments, Surgical, Cardiovascular
- FQHLavage, Jet
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- DQTOccluder, Catheter Tip
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
