The following data is part of a premarket notification filed by Boston Scientific Ivt with the FDA for 2 Cm Peripheral Cutting Baloon.
| Device ID | K041993 |
| 510k Number | K041993 |
| Device Name: | 2 CM PERIPHERAL CUTTING BALOON |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | BOSTON SCIENTIFIC IVT 3574 RUFFIN RD. San Diego, CA 92123 -3597 |
| Contact | Renuka Krishnan |
| Correspondent | Renuka Krishnan BOSTON SCIENTIFIC IVT 3574 RUFFIN RD. San Diego, CA 92123 -3597 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-08-16 |
| Summary: | summary |