Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
FDA 510(k) K003880 · Concentric Medical, Inc.
510(k) numberK003880
Submission
- Device name
- Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
- Applicant
- Concentric Medical, Inc.
Moutian View, CA, US - Received
- December 15, 2000
- Decision date
- May 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) cleared by the FDA?
Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) (K003880) received a 510(k) decision of Substantially Equivalent on May 16, 2001, 152 days after the submission was received.
What is the product code of K003880?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.