0.2 U Bacterial Filter
FDA 510(k) K974661 · Sims Deltec, Inc.
510(k) numberK974661
Submission
- Device name
- 0.2 U Bacterial Filter
- Applicant
- Sims Deltec, Inc.
St. Paul, MN, US - Received
- December 15, 1997
- Decision date
- February 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K991255 | Cadd-Tpn Administration Set, Model 21-7071FPA · Traditional | 06/09/1999SE |
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Questions and answers
When was 0.2 U Bacterial Filter cleared by the FDA?
0.2 U Bacterial Filter (K974661) received a 510(k) decision of Substantially Equivalent on February 11, 1998, 58 days after the submission was received.
What is the product code of K974661?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.