K965229 is an FDA 510(k) clearance for the IMAGER TORQUE CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 4, 1997, 63 days after receiving the submission on December 31, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K965229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1996 |
| Decision Date | March 04, 1997 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |