K864897 is an FDA 510(k) clearance for the DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335. This device is classified as a Tourniquet, Nonpneumatic (Class I - General Controls, product code GAX).
Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on January 12, 1987, 28 days after receiving the submission on December 15, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5900.
| 510(k) Number | K864897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1986 |
| Decision Date | January 12, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAX — Tourniquet, Nonpneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5900 |