Recruit Microcatheter
FDA 510(k) K091563 · Reverse Medical Corporation
510(k) numberK091563
Submission
- Device name
- Recruit Microcatheter
- Applicant
- Reverse Medical Corporation
Irvine, CA, US - Received
- May 28, 2009
- Decision date
- July 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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More from Merit Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150108 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 04/22/2015SE |
| K141313 | Reverse Medical Micro Vascular Plug SystemKRD · Special | 06/18/2014SE |
| K133282 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Special | 11/27/2013SE |
| K130858 | Reverse Medical MicrocatheterDQY · Traditional | 10/11/2013SE |
| K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Traditional | 07/02/2013SE |
| K122684 | Reverse Medical MicrocatheterDQY · Traditional | 12/07/2012SE |
| K112262 | Reflex Ballon Guide CatheterDQY · Traditional | 11/02/2011SE |
| K102418 | Reverse Medical Report Guide Catheter SystemDQY · Traditional | 04/15/2011SE |
| K110055 | Reverse Medical Reflex Guide CatheterDQY · Traditional | 04/05/2011SE |
Questions and answers
When was Recruit Microcatheter cleared by the FDA?
Recruit Microcatheter (K091563) received a 510(k) decision of Substantially Equivalent on July 30, 2009, 63 days after the submission was received.
What is the product code of K091563?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.