Submission Details
| 510(k) Number | K853791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 1985 |
| Decision Date | December 09, 1985 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
K853791 - NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
(FDA 510(k) Clearance)
Dec 1985
Decision
89d
Days
Class 2
Risk
K853791 is an FDA 510(k) clearance for the NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Norton Performance Plastics Corp. (Akron, US). The FDA issued a Cleared decision on December 9, 1985, 89 days after receiving the submission on September 11, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.
Device Classification
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4240 |
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