Biocardia Universal Deflectable Guide Catheter, Model 000664
FDA 510(k) K012749 · Biocardia, Inc.
510(k) numberK012749
Submission
- Device name
- Biocardia Universal Deflectable Guide Catheter, Model 000664
- Applicant
- Biocardia, Inc.
South San Francisco, CA, US - Received
- August 16, 2001
- Decision date
- January 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Biocardia Universal Deflectable Guide Catheter, Model 000664 cleared by the FDA?
Biocardia Universal Deflectable Guide Catheter, Model 000664 (K012749) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 161 days after the submission was received.
What is the product code of K012749?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.