Reverse Medical Microcatheter
FDA 510(k) K122684 · Reverse Medical Corporation
510(k) numberK122684
Submission
- Device name
- Reverse Medical Microcatheter
- Applicant
- Reverse Medical Corporation
Irvine, CA, US - Received
- August 31, 2012
- Decision date
- December 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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More from Abbott Medical
| 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 |
| 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 |
| K091563 | Recruit MicrocatheterMMX · Traditional | 07/30/2009SE |
Questions and answers
When was Reverse Medical Microcatheter cleared by the FDA?
Reverse Medical Microcatheter (K122684) received a 510(k) decision of Substantially Equivalent on December 7, 2012, 98 days after the submission was received.
What is the product code of K122684?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.