HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

Analyzer, Heparin, Automated

MEDTRONIC HEMOTEC, INC.

The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Hms Purple And Black Heparin Cartridges & Control.

Pre-market Notification Details

• Device ID: K922031
• 510k Number: K922031
• Device Name: HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
• Classification: Analyzer, Heparin, Automated
• Applicant: MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112
• Contact: Dessie Fafoutis
• Correspondent: Dessie Fafoutis; MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112
• Product Code: JOX
• CFR Regulation Number: 864.5680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-05-01
• Decision Date: 1992-07-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994697268	K922031	000
20613994697251	K922031	000
00643169713246	K922031	000
00643169713239	K922031	000