K874242 is an FDA 510(k) clearance for the JEHLE CORONARY PERFUSION CATHETERS. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on December 7, 1987, 52 days after receiving the submission on October 16, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K874242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1987 |
| Decision Date | December 07, 1987 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |