North Coast Medi-Tek
Country not established
- Devices
- 6
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What North Coast Medi-Tek makes
North Coast Medi-Tek manufactures single-use disposable trays and accessories for interventional radiology procedures, including angiography, arthrogram, percutaneous cholangiography, myelogram, and biopsy trays. Their product line also includes lumbar puncture extension sets designed for sterile fluid transfer during diagnostic or therapeutic interventions.
The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. Their products are registered in the U.S. under FDA regulations, and the manufacturer is based in the United States.
Catalogue
Ivr-Sp Custom Angiography Tray Ref K870419
Regimes: 510(k) Registry: 510(k)Rct-1, Rct-2, Rct-3 Arthrogram Tray Ref K870417
Regimes: 510(k) Registry: 510(k)Ptc-6 And Ptc-8 Percutaneous Cholangiography Ref K870420
Regimes: 510(k) Registry: 510(k)Mya-1 And Myt-1 Myelogram Tray Ref K870418
Regimes: 510(k) Registry: 510(k)Biopsy Tray I & Ii Ref K854095
Regimes: 510(k) Registry: 510(k)LP Extension Sets Ref K870416
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by North Coast Medi-Tek, the earliest on 2004-06-23 and the most recent on 2011-05-13. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 13 May 2011 Z-2982-2011 Unclassified (pre-2012) Terminated During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level is 23,000 CFU.
2005
- 7 Jun 2005 Z-1571-05 Unclassified (pre-2012) Terminated Customer observed unsealed packages.
- 18 Jan 2005 Z-1572-05 Unclassified (pre-2012) Terminated Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
Full distribution text
2004
- 23 Jun 2004 Z-1523-05 Unclassified (pre-2012) Terminated Product contains the incorrect lot number.
Frequently asked questions
How many devices does North Coast Medi-Tek have in the registry?
The registry currently lists 6 devices for North Coast Medi-Tek. Devices recorded under merged duplicate company entries are counted once.
Which registries list North Coast Medi-Tek's devices?
Among its 6 most recently registered devices, North Coast Medi-Tek has devices listed in FDA 510(k) (6 devices).
What risk classes do North Coast Medi-Tek's devices fall under?
Among its 6 most recently registered devices, the classes recorded for North Coast Medi-Tek's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for North Coast Medi-Tek?
FDA recall records list 4 recalls initiated by North Coast Medi-Tek, the most recent initiated on 13 May 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from North Coast Medi-Tek in the registry?
The most recently registered devices listed for North Coast Medi-Tek include IVR-SP CUSTOM ANGIOGRAPHY TRAY, RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY, PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY and MYA-1 AND MYT-1 MYELOGRAM TRAY.