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FDA 510(k)

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE

K-Number: K915577 · 1992-03-11

ApplicantImpra, Inc.
Decision Date1992-03-11
Product CodeCAR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K915577. The device is classified under product code CAR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE?

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Impra, Inc.. The 510(k) number is K915577.

When did IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE receive FDA 510(k) clearance?

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE received FDA 510(k) clearance on 1992-03-11, under 510(k) number K915577.

Who is the listed applicant for IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE?

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

What is the FDA product code for IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE?

The FDA product code for IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE is CAR.

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Other records listing Impra, 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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSK004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSK991027BI-DIRECTIONAL TUNNELERK983769DISTAFLO BYPASS GRAFTK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFT

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Related Devices (Code: CAR)

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.

K920740EPISENSOR PLUSIndustrias Palex C/O Dma Med-Chem Corp.K926066BION MUMPS-G ANTIBODY TEST SYSTEMBion Ent., Ltd.

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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