Recovery Cone Removal System
FDA 510(k) K152136 · C.R. Bard, Inc.
510(k) numberK152136
Submission
- Device name
- Recovery Cone Removal System
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- July 31, 2015
- Decision date
- February 18, 2016
- 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 Recovery Cone Removal System cleared by the FDA?
Recovery Cone Removal System (K152136) received a 510(k) decision of Substantially Equivalent on February 18, 2016, 202 days after the submission was received.
What is the product code of K152136?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.