North American Instrument Corp.
Walker, MI, US
North American Instrument Corp. appears in FDA device records in Walker, MI. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for North American Instrument Corp. between 1983 and 1996. The busiest year on record is 1987, with 4. The most recent is 1996, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 2 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 1 |
| 1996 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960801 | SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) | DQO | Substantially Equivalent | |
| K955554 | HEMO-VALVE | DTL | Substantially Equivalent | |
| K960310 | EPIC INTRODUCER SHEATH | DYB | Substantially Equivalent | |
| K922552 | MORSE(R) ANGIOGRAPHIC CATHETERS | DQO | Substantially Equivalent | |
| K915078 | MORSE HEMOSTATIC CATHETER INTRODUCER SET | DYB | Substantially Equivalent | |
| K905208 | MORSE ANESTHESIA | FPA | Substantially Equivalent | |
| K912961 | MORSE VASCULAR INTRODUCER SET | DYB | Substantially Equivalent | |
| K910764 | THE PERCEPTOR(TM) STAND ALONE TRANSDUCER | DRS | Substantially Equivalent | |
| K903493 | NAMIC CONTRAST SAVINGS DELIVERY SYSTEM | IZI | Substantially Equivalent | |
| K904275 | MORSE BALLOON INFLATION DEVICE | MAV | Substantially Equivalent | |
| K903606 | GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER | LIT | Substantially Equivalent | |
| K902472 | MORSE DT MANIFOLD | DRS | Substantially Equivalent | |
| K900652 | NAMIC PTCA Y-ADAPTOR | DTL | Substantially Equivalent | |
| K896087 | PALESTRANT IRRIGATION AND DRAINAGE SET | KGZ | Substantially Equivalent | |
| K890580 | LIPID STOPCOCK | DTL | Substantially Equivalent | |
| K885090 | HOMER MAMMALOK LOCALIZATION SHIELD | LRO | Substantially Equivalent | |
| K884408 | NAMIC DUAL BACKCHECK VALVE | DTL | Substantially Equivalent | |
| K873955 | NAMIC ANGIOGRAPHIC SYRINGE | DXT | Substantially Equivalent | |
| K873954 | NAMIC HAWKINS UNIVERSAL DRAINAGE SET | FGE | Substantially Equivalent | |
| K871377 | NAMIC COURNAND STYLE INTRODUCER NEEDLE | DRC | Substantially Equivalent | |
| K871382 | NAMIC ONE PART INTRODUCER NEEDLE | DRC | Substantially Equivalent | |
| K871378 | NAMIC SELDINGER INTRODUCER NEEDLE | DRC | Substantially Equivalent | |
| K864800 | NAMIC CHIBA ASPIRATION BIOPSY NEEDLE | GAA | Substantially Equivalent | |
| K852402 | NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER | FZX | Substantially Equivalent | |
| K852140 | NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) | FPA | Substantially Equivalent | |
| K843726 | NAMIC ADB ANGIOGRAPHIC DUMP BAG | DQO | Substantially Equivalent | |
| K842829 | HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS | DTL | Substantially Equivalent | |
| K833271 | NAMIC CONTINUOUS FLUSH DEVICE | DRS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KGZAccessories, Catheter
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DQOCatheter, Intravascular, Diagnostic
- LROGeneral Surgery Tray
- FZXGuide, Surgical, Instrument
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- GAANeedle, Aspiration And Injection, Disposable
- FPASet, Administration, Intravascular
- FGEStents, Drains And Dilators For The Biliary Ducts
- MAVSyringe, Balloon Inflation
- IZISystem, X-Ray, Angiographic
- DRSTransducer, Blood-Pressure, Extravascular
- DRCTrocar
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