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FDA 510(k)

SAFE-1

K-Number: K893704 · 1989-12-22

ApplicantPolystan C/O Vitalcor, Inc.
Decision Date1989-12-22
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE-1 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 1989-12-22 under 510(k) number K893704. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-1?

SAFE-1 is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Polystan C/O Vitalcor, Inc.. The 510(k) number is K893704.

When did SAFE-1 receive FDA 510(k) clearance?

SAFE-1 received FDA 510(k) clearance on 1989-12-22, under 510(k) number K893704.

Who is the listed applicant for SAFE-1?

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 SAFE-1?

The FDA product code for SAFE-1 is DTZ.

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.

K894657POLYSTAN HEART-LUNG MACHINE SYSTEMK893940POLYSTAN HEATER-COOLER UNITK893705SAFE-1 VENOUS RESERVOIRK874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSK874853POLYSTAN TWO STAGE CATHETERSK872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

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Related Devices (Code: DTZ)

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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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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