Modification to Modified HD Guide Catheter
FDA 510(k) K092298 · Concentric Medical, Inc.
510(k) numberK092298
Submission
- Device name
- Modification to Modified HD Guide Catheter
- Applicant
- Concentric Medical, Inc.
Mountain View, CA, US - Received
- July 29, 2009
- Decision date
- November 5, 2009
- 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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Questions and answers
When was Modification to Modified HD Guide Catheter cleared by the FDA?
Modification to Modified HD Guide Catheter (K092298) received a 510(k) decision of Substantially Equivalent on November 5, 2009, 99 days after the submission was received.
What is the product code of K092298?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.