The following data is part of a premarket notification filed by Scimed with the FDA for Scimed Transport Steerable Guide Wire And Access..
| Device ID | K931584 |
| 510k Number | K931584 |
| Device Name: | SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 -2644 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 -2644 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-31 |
| Decision Date | 1993-07-01 |