Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72
FDA 510(k) K982822 · Baxter Healthcare Corp
510(k) numberK982822
Submission
- Device name
- Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72
- Applicant
- Baxter Healthcare Corp
Round Lake, IL, US - Received
- August 11, 1998
- Decision date
- September 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAK – Microfilter, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72 cleared by the FDA?
Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72 (K982822) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 50 days after the submission was received.
What is the product code of K982822?
The FDA product code is CAK – Microfilter, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.