K951506 is an FDA 510(k) clearance for the SUCTION CATHETER KIT, STERILE, SINGLE-USE. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on July 3, 1995, 91 days after receiving the submission on April 3, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K951506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | July 03, 1995 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6810 |