The following data is part of a premarket notification filed by Medical Surgical Concepts, Inc. with the FDA for Percutaneous Sheath W/wo Medi. (5,6,7,8,8.5fr).
| Device ID | K870413 |
| 510k Number | K870413 |
| Device Name: | PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MEDICAL SURGICAL CONCEPTS, INC. 725 W. SECOND ST. Lansdale, PA 19446 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz MEDICAL SURGICAL CONCEPTS, INC. 725 W. SECOND ST. Lansdale, PA 19446 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-06-01 |