The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Smith Medical Peel-away Sheath Introducers.
| Device ID | K112407 |
| 510k Number | K112407 |
| Device Name: | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS |
| Classification | Introducer, Catheter |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Tom Bliss |
| Correspondent | Tom Bliss SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-02-09 |
| Summary: | summary |