Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189
FDA 510(k) K013789 · Boston Scientific, Target
510(k) numberK013789
Submission
- Device name
- Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189
- Applicant
- Boston Scientific, Target
Fremont, CA, US - Received
- November 14, 2001
- Decision date
- December 6, 2001
- 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 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 cleared by the FDA?
Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 (K013789) received a 510(k) decision of Substantially Equivalent on December 6, 2001, 22 days after the submission was received.
What is the product code of K013789?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.