K780438 is an FDA 510(k) clearance for the SAFETY SPRING GUIDES, TEFLON COATED. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978, 100 days after receiving the submission on March 20, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K780438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1978 |
| Decision Date | June 28, 1978 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |