Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]
FDA 510(k) K121382 · Westmed, Inc.
510(k) numberK121382
Submission
- Device name
- Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]
- Applicant
- Westmed, Inc.
Tucson, AZ, US - Received
- May 8, 2012
- Decision date
- December 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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Questions and answers
When was Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)] cleared by the FDA?
Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)] (K121382) received a 510(k) decision of Substantially Equivalent on December 6, 2012, 212 days after the submission was received.
What is the product code of K121382?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.