The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Angiographic Catheter For Laporoscopic Use.
Device ID | K926217 |
510k Number | K926217 |
Device Name: | TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE |
Classification | Catheter, Cholangiography |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-10 |
Decision Date | 1993-07-13 |