Concentric Retriever, Model 90030
FDA 510(k) K003410 · Concentric Medical, Inc.
510(k) numberK003410
Submission
- Device name
- Concentric Retriever, Model 90030
- Applicant
- Concentric Medical, Inc.
Moutian View, CA, US - Received
- November 2, 2000
- Decision date
- May 22, 2001
- 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 Concentric Retriever, Model 90030 cleared by the FDA?
Concentric Retriever, Model 90030 (K003410) received a 510(k) decision of Substantially Equivalent on May 22, 2001, 201 days after the submission was received.
What is the product code of K003410?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.