Biocardia Morph Universal Deflectable Guide Catheter
FDA 510(k) K042553 · Biocardia, Inc.
510(k) numberK042553
Submission
- Device name
- Biocardia Morph Universal Deflectable Guide Catheter
- Applicant
- Biocardia, Inc.
South San Francisco, CA, US - Received
- September 20, 2004
- Decision date
- February 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Biocardia Morph Universal Deflectable Guide Catheter cleared by the FDA?
Biocardia Morph Universal Deflectable Guide Catheter (K042553) received a 510(k) decision of Substantially Equivalent on February 17, 2005, 150 days after the submission was received.
What is the product code of K042553?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.