The following data is part of a premarket notification filed by Innerdyne Medical, Inc. with the FDA for Intherm Radially Expanding Dilating Introducer.
| Device ID | K931489 |
| 510k Number | K931489 |
| Device Name: | INTHERM RADIALLY EXPANDING DILATING INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | INNERDYNE MEDICAL, INC. 2665 MARINE WAY Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INNERDYNE MEDICAL, INC. 2665 MARINE WAY Mountain View, CA 94043 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-25 |
| Decision Date | 1993-10-15 |