PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C— 510(k) K080174

Substantially Equivalent

Cardio Med Supplies, Inc.

FDA 510(k) clearance K080174 for PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C, Substantially Equivalent on 2008-04-23. Applicant: Cardio Med Supplies, Inc..

Clearance details

Applicant: Cardio Med Supplies, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2008-01-24
Decision date: 2008-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lindsay-Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.