In-Time Retrieval Device
FDA 510(k) K014109 · Boston Scientific, Target
510(k) numberK014109
Submission
- Device name
- In-Time Retrieval Device
- Applicant
- Boston Scientific, Target
Fremont, CA, US - Received
- December 14, 2001
- Decision date
- March 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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Questions and answers
When was In-Time Retrieval Device cleared by the FDA?
In-Time Retrieval Device (K014109) received a 510(k) decision of Substantially Equivalent on March 12, 2002, 88 days after the submission was received.
What is the product code of K014109?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.