AFX INTRODUCER SYSTEM
FDA 510(k) clearance K120212 · decided 2012-02-09
Clearance details
- K-number
- K120212
- Device name
- AFX INTRODUCER SYSTEM
- Applicant
- Endologix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-24
- Decision date
- 2012-02-09
- Days to decision
- 16 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Endologix
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 10 recall (Z-1436-2013) | Endologix Inc | 2013-06-07 |
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 |