K874367 is an FDA 510(k) clearance for the VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF. This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).
Submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on January 4, 1988, 73 days after receiving the submission on October 23, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K874367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1987 |
| Decision Date | January 04, 1988 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQO — Unit, Cautery, Thermal, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |