The Crosser 14 Otw Catheter, Model CRU014
FDA 510(k) K091254 · Flowcardia, Inc.
510(k) numberK091254
Submission
- Device name
- The Crosser 14 Otw Catheter, Model CRU014
- Applicant
- Flowcardia, Inc.
Sunnyvale, CA, US - Received
- April 29, 2009
- Decision date
- May 29, 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 The Crosser 14 Otw Catheter, Model CRU014 cleared by the FDA?
The Crosser 14 Otw Catheter, Model CRU014 (K091254) received a 510(k) decision of Substantially Equivalent on May 29, 2009, 30 days after the submission was received.
What is the product code of K091254?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.