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FDA 510(k)

POLYSTAN HEATER-COOLER UNIT

K-Number: K893940 · 1990-01-18

ApplicantPolystan C/O Vitalcor, Inc.
Decision Date1990-01-18
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYSTAN HEATER-COOLER UNIT 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 1990-01-18 under 510(k) number K893940. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSTAN HEATER-COOLER UNIT?

POLYSTAN HEATER-COOLER UNIT is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is Polystan C/O Vitalcor, Inc.. The 510(k) number is K893940.

When did POLYSTAN HEATER-COOLER UNIT receive FDA 510(k) clearance?

POLYSTAN HEATER-COOLER UNIT received FDA 510(k) clearance on 1990-01-18, under 510(k) number K893940.

Who is the listed applicant for POLYSTAN HEATER-COOLER UNIT?

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 HEATER-COOLER UNIT?

The FDA product code for POLYSTAN HEATER-COOLER UNIT is DWC.

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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.

K894657POLYSTAN HEART-LUNG MACHINE SYSTEMK893704SAFE-1K893705SAFE-1 VENOUS RESERVOIRK874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSK874853POLYSTAN TWO STAGE CATHETERSK872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

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Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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