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FDA 510(k)

POLYSTAN TWO STAGE CATHETERS

K-Number: K874853 · 1988-02-05

ApplicantPolystan C/O Vitalcor, Inc.
Decision Date1988-02-05
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYSTAN TWO STAGE CATHETERS 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 1988-02-05 under 510(k) number K874853. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSTAN TWO STAGE CATHETERS?

POLYSTAN TWO STAGE CATHETERS is a medical device that received FDA 510(k) clearance on 1988-02-05. The listed applicant is Polystan C/O Vitalcor, Inc.. The 510(k) number is K874853.

When did POLYSTAN TWO STAGE CATHETERS receive FDA 510(k) clearance?

POLYSTAN TWO STAGE CATHETERS received FDA 510(k) clearance on 1988-02-05, under 510(k) number K874853.

Who is the listed applicant for POLYSTAN TWO STAGE CATHETERS?

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 TWO STAGE CATHETERS?

The FDA product code for POLYSTAN TWO STAGE CATHETERS is DWF.

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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 SYSTEMK893940POLYSTAN HEATER-COOLER UNITK893705SAFE-1 VENOUS RESERVOIRK893704SAFE-1K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSK872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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