BioCardia 8F Morph DNA Deflectable Guide Catheter
FDA 510(k) K192774 · Biocardia
510(k) numberK192774
Submission
- Device name
- BioCardia 8F Morph DNA Deflectable Guide Catheter
- Applicant
- Biocardia
San Carlos, CA, US - Received
- September 30, 2019
- Decision date
- January 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K242169 | Morph DNA Steerable Introducer SheathDYB · Special | 08/23/2024SE |
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| K042553 | Biocardia Morph Universal Deflectable Guide CatheterDQY · Traditional | 02/17/2005SE |
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Questions and answers
When was BioCardia 8F Morph DNA Deflectable Guide Catheter cleared by the FDA?
BioCardia 8F Morph DNA Deflectable Guide Catheter (K192774) received a 510(k) decision of Substantially Equivalent on January 7, 2020, 99 days after the submission was received.
What is the product code of K192774?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.