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FDA 510(k)

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C

K-Number: K080174 · 2008-04-23

Decision Date2008-04-23
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Med Supplies, Inc.. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080174. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C?

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Cardio Med Supplies, Inc.. The 510(k) number is K080174.

When did PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C receive FDA 510(k) clearance?

PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080174.

Who is the listed applicant for PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C?

The FDA 510(k) record lists Cardio Med Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C?

The FDA product code for PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C is LHI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Cardio Med Supplies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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