The following data is part of a premarket notification filed by Interventional Therapeutics Corp. with the FDA for Percutaneous Dilator With Sheath.
| Device ID | K913932 |
| 510k Number | K913932 |
| Device Name: | PERCUTANEOUS DILATOR WITH SHEATH |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Contact | Colin J Nichols |
| Correspondent | Colin J Nichols INTERVENTIONAL THERAPEUTICS CORP. 2665 MARINE WAY Mountain View, CA 94043 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1991-11-22 |