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FDA 510(k)

CARDIO-PAK BASIC PUMP PACK

K-Number: K923231 · 1993-07-09

ApplicantCardio-Med-Associates, Inc.
Decision Date1993-07-09
Product CodeDWE
Advisory CommitteeCV
DecisionUnknown

Device Summary

CARDIO-PAK BASIC PUMP PACK is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Med-Associates, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K923231. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CARDIO-PAK BASIC PUMP PACK?

CARDIO-PAK BASIC PUMP PACK is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Cardio-Med-Associates, Inc.. The 510(k) number is K923231.

When did CARDIO-PAK BASIC PUMP PACK receive FDA 510(k) clearance?

CARDIO-PAK BASIC PUMP PACK received FDA 510(k) clearance on 1993-07-09, under 510(k) number K923231.

Who is the listed applicant for CARDIO-PAK BASIC PUMP PACK?

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

What is the FDA product code for CARDIO-PAK BASIC PUMP PACK?

The FDA product code for CARDIO-PAK BASIC PUMP PACK is DWE.

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.

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Other records listing Cardio-Med-Associates, 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.

K923233CARDIO-PAK LAPAROTOMY PACK

Related Devices (Code: DWE)

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.

K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc.K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AGK053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AGK022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems CorporationK013578PUMP TUBINGTerumo Cardiovascular Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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