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Poly Braided Pigtail/Perc Card Cath W/Var Tip Conf

by The R Group

510(k) K912076

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912076 Date30 Jul 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a catheter, intravascular, diagnostic designed for cardiac procedures. It features a poly braided construction and a pigtail-shaped tip, optimized for percutaneous insertion into coronary arteries to facilitate angiography and interventional cardiology tasks.

The catheter is supplied as a single-use, non-sterile device (sterilized prior to use) and is classified under FDA regulation 870.1200. It is intended for use in cardiovascular settings, with a variable tip configuration to enhance maneuverability. Authorized under FDA 510(k) clearance (K912076), it was determined substantially equivalent to the predicate device in 1991.

Other devices from The R Group

Questions

AI-generated answers, 19 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 types of cardiac procedures is this catheter designed to assist with, and why is the pigtail tip shape important?

    This catheter is designed specifically for angiography and interventional cardiology tasks, such as coronary artery imaging and guiding interventions. The pigtail-shaped tip enhances maneuverability within coronary arteries, allowing for precise navigation and positioning during procedures. The poly braided construction also provides added flexibility and torque control, which is critical for navigating the complex anatomy of coronary vessels.

  • Is this catheter intended for single-use or repeated use, and how should it be prepared before use?

    This catheter is single-use only and is supplied in a non-sterile state. It must be sterilized prior to use as part of standard clinical preparation. Sterilization should follow established protocols to ensure safety and efficacy before insertion into a patient.

  • What does the variable tip configuration mean, and how might it benefit a clinician during a procedure?

    The variable tip configuration refers to the catheter’s adaptable tip design, which allows for optimized maneuverability in different coronary artery geometries. This feature helps clinicians achieve better control and precision during angiography or interventional procedures, reducing the risk of misplacement or trauma to the vessel walls.

  • How should this catheter be stored, and what storage conditions are recommended?

    Since this is a single-use, non-sterile device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. The packaging should remain intact until sterilization is performed prior to use. Follow manufacturer guidelines for proper handling to maintain device integrity.