K911100 is an FDA 510(k) clearance for the MEHIGAN-PILLING PHLEBETOME TM. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on June 21, 1991, 101 days after receiving the submission on March 12, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K911100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1991 |
| Decision Date | June 21, 1991 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | MGZ — Valvulotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |