K961219 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER SYSTEM. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on June 21, 1996, 85 days after receiving the submission on March 28, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K961219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1996 |
| Decision Date | June 21, 1996 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |