AFX INTRODUCER SYSTEM
FDA 510(k) clearance K110090 · decided 2011-05-26
Clearance details
- K-number
- K110090
- Device name
- AFX INTRODUCER SYSTEM
- Applicant
- Endologix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-12
- Decision date
- 2011-05-26
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER (P970052/S002) | Endologix, Inc. | 1998-05-19 |
| LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). (P970052/S001) | Endologix, Inc. | 1998-04-08 |
| FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS (P970052) | Endologix, Inc. | 1998-02-20 |