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Cook Chorionic Villus Sampling Set

by Cook Incorporated

PMA P900007

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P900007↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP900007 Date30 Sep 1994ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Catheter, sampling, chorionic villus
PMA number
FDA product code
LLX
Device class
Class III
Advisory committee
Obstetrics/Gynecology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cook Chorionic Villus Sampling Set is a medical device categorized as a chorionic villus sampling catheter. It is designed to facilitate the collection of tissue samples from the chorionic villi for diagnostic purposes.

This device is manufactured by Cook Incorporated and is authorized for use under FDA PMA number P900007. It is intended for clinical use within the field of obstetrics and gynecology.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Cook Chorionic Villus Sampling Set?

    The device is a specialized catheter designed to perform chorionic villus sampling, which is a procedure used to collect tissue samples for diagnostic testing.

  • Is the Cook Chorionic Villus Sampling Set FDA authorized?

    Yes, the device is authorized for use under FDA PMA number P900007, which was granted following the regulatory review process.

  • What medical specialty is this device associated with?

    The device is classified under the obstetrics and gynecology advisory committee, reflecting its application in prenatal diagnostic procedures.