K851140 is an FDA 510(k) clearance for the TELEFLEX MEDICAL INTRODUCER NEEDLE. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on June 19, 1985, 90 days after receiving the submission on March 21, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K851140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1985 |
| Decision Date | June 19, 1985 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWS — Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |