Submission Details
| 510(k) Number | K943739 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 1994 |
| Decision Date | November 15, 1994 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
Nov 1994
Decision
105d
Days
Class 2
Risk
About This 510(k) Submission
K943739 is an FDA 510(k) clearance for the SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on November 15, 1994, 105 days after receiving the submission on August 2, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
Manufacturer
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