Company ยท US
North Coast Medi-Tek
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1987. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 11, 1987 | K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY North Coast Medi-Tek | DQO |
| Apr 14, 1987 | K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY North Coast Medi-Tek | GBZ |
| Apr 6, 1987 | K870416 | LP EXTENSION SETS North Coast Medi-Tek | FPK |
| Mar 17, 1987 | K870418 | MYA-1 AND MYT-1 MYELOGRAM TRAY North Coast Medi-Tek | |
| Mar 5, 1987 | K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY North Coast Medi-Tek | FSM |
| Nov 25, 1985 | K854095 | BIOPSY TRAY I & II North Coast Medi-Tek | LRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2011 | North Coast Medi-Tek Inc Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case.
Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used i Terminated |
LOR | K854095 |
| Sep 21, 2005 | North Coast Medi-Tek Inc SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case. Terminated |
LRO | K854095 |
| Sep 21, 2005 | North Coast Medi-Tek Inc Ultrasound probe cover, sterile. Catalog No. 910811. Terminated |
KKX | K050322 |
| Sep 8, 2005 | North Coast Medi-Tek Inc E-Z-EM brand, Basic biopsy tray, catalog no. 4125. Terminated |
LRO | K854095 |