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FDA 510(k)

POLYSTAN HEART-LUNG MACHINE SYSTEM

K-Number: K894657 · 1990-03-28

ApplicantPolystan C/O Vitalcor, Inc.
Decision Date1990-03-28
Product CodeDJQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

POLYSTAN HEART-LUNG MACHINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Polystan C/O Vitalcor, Inc.. It received FDA 510(k) clearance on 1990-03-28 under 510(k) number K894657. The device is classified under product code DJQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSTAN HEART-LUNG MACHINE SYSTEM?

POLYSTAN HEART-LUNG MACHINE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-28. The listed applicant is Polystan C/O Vitalcor, Inc.. The 510(k) number is K894657.

When did POLYSTAN HEART-LUNG MACHINE SYSTEM receive FDA 510(k) clearance?

POLYSTAN HEART-LUNG MACHINE SYSTEM received FDA 510(k) clearance on 1990-03-28, under 510(k) number K894657.

Who is the listed applicant for POLYSTAN HEART-LUNG MACHINE SYSTEM?

The FDA 510(k) record lists Polystan C/O Vitalcor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYSTAN HEART-LUNG MACHINE SYSTEM?

The FDA product code for POLYSTAN HEART-LUNG MACHINE SYSTEM is DJQ.

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Other records listing Polystan C/O Vitalcor, 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.

K893940POLYSTAN HEATER-COOLER UNITK893704SAFE-1K893705SAFE-1 VENOUS RESERVOIRK874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSK874853POLYSTAN TWO STAGE CATHETERSK872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

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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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