Manual Retraction Kit
FDA premarket approval P100010/S136 · decided 2023-02-28
Approval details
- PMA number
- P100010
- Supplement
- S136
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Manual Retraction Kit
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2023-01-30
- Decision date
- 2023-02-28
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transfer of the Arctic Front family of Cardiac Cryoablation Catheters and its Manual Retraction Kit Accessory (20MRK) from Medtronic's Montreal facility to Medtronic's Tijuana Mexico facility in addition to the implementation of manufacturing changes and minor updates to the packaging design.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FlexCath Advance Steerable Sheath and Dilator (K202620) | Medtronic Cryocath, LP | 2020-11-13 |
| FlexCath Advance Steerable Sheath and Dilator (K183174) | Medtronic Cryocath, LP | 2018-11-26 |
| FlexCath Select Steerable Shealth and Dilator (K163268) | Medtronic Cryocath, LP | 2017-02-02 |
| FlexCath Select Steerable Sheath (10 French) (K142684) | Medtronic Cryocath, LP | 2014-11-06 |
| FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591) | Medtronic Cryocath, LP | 2012-12-27 |
| FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176) | Medtronic Cryocath, LP | 2010-09-01 |