ILT DEFLECTING CATHETER, MODEL C114ND1
Device Facts
| Record ID | K010531 |
|---|---|
| Device Name | ILT DEFLECTING CATHETER, MODEL C114ND1 |
| Applicant | Intra Luminal Therapeutics, Inc. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Apr 18, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.