The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Peripherally Inserted Central Venous Catheter.
Device ID | K871080 |
510k Number | K871080 |
Device Name: | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER |
Classification | Catheter, Percutaneous |
Applicant | CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Colin J Nichols |
Correspondent | Colin J Nichols CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-18 |
Decision Date | 1987-08-12 |