K101199 is an FDA 510(k) clearance for the GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Maquet Critical Care AB (Wayne, US). The FDA issued a Cleared decision on August 27, 2010, 120 days after receiving the submission on April 29, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K101199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2010 |
| Decision Date | August 27, 2010 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT - Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |