Offroad Re-Entry Catheter System
510(k) K131914
Offroad Re-Entry Catheter System is a medical device (FDA Class II; FDA product code PDU, Catheter For Crossing Total Occlusions) made by Boston Scientific, cleared under FDA 510(k) K131914 on 31 Oct 2013, 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 | NumberK131914 | Date31 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K131914
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- Withdrawn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
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