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FDA 510(k)

VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.

K-Number: K900483 · 1990-08-29

ApplicantBaxter Healthcare Corp
Decision Date1990-08-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-08-29 under 510(k) number K900483. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.?

VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. is a medical device that received FDA 510(k) clearance on 1990-08-29. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K900483.

When did VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. receive FDA 510(k) clearance?

VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. received FDA 510(k) clearance on 1990-08-29, under 510(k) number K900483.

Who is the listed applicant for VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.?

The FDA product code for VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. is CAC.

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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