Submission Details
| 510(k) Number | K022431 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 25, 2002 |
| Decision Date | September 05, 2002 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
MEDRAD TRANSFER SET
Sep 2002
Decision
42d
Days
Class 2
Risk
About This 510(k) Submission
K022431 is an FDA 510(k) clearance for the MEDRAD TRANSFER SET, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on September 5, 2002, 42 days after receiving the submission on July 25, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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