Truepath Cto Device
510(k) K140288
Truepath Cto Device is a Class II device made by Boston Scientific, cleared under FDA 510(k) K140288 on 16 Apr 2014, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140288 | Date16 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K140288
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PDU
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PDU (Catheter For Crossing Total Occlusions).
- SoundBite Console, SoundBite Active Wire 18 by Soundbite Medical Solution, Inc.
- CLIRPATH TURBO EXCIMER LASER CATHETERS by Spectranetics Corporation
- Tigereye CTO-Crossing Catheter by AVINGER, INC.
- WILDCAT CATHETER by AVINGER, INC.
- CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 by Spectranetics Corporation
- MICRO GUIDE CATHETER ELITE by Cordis Corp., A Johnson & Johnson Co.
- MODIFICATION TO THE CROSSER SYSTEM by Flowcardia, Inc.
- Bigboss Mantatay Catheter Mantaray Guidewires by Bridgepoint Medical
- Frontrunner CTO Catheter and Accessories by Lumend, Inc.
- RA-308 Excimer Laser System, Excimer Laser Catheter by Ra Medical Systems, Inc