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 |