The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Clottrac Coagulation Control.
Device ID | K923594 |
510k Number | K923594 |
Device Name: | CLOTTRAC COAGULATION CONTROL |
Classification | Activated Whole Blood Clotting Time |
Applicant | MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
Contact | Lisa Norris |
Correspondent | Lisa Norris MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
Product Code | JBP |
CFR Regulation Number | 864.7140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-20 |
Decision Date | 1992-09-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20763000014852 | K923594 | 000 |
20763000014845 | K923594 | 000 |
20763000014838 | K923594 | 000 |