K914984 is an FDA 510(k) clearance for the E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on May 20, 1992, 210 days after receiving the submission on October 23, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K914984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1991 |
| Decision Date | May 20, 1992 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |