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Vasco Tip/Vascoflange

by Vascor Medical Corp.

510(k) K913831

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 NumberK913831 Date25 Aug 1993ClearedStatusActive

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  • Withdrawn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
DTB
Device Class
Class III
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 Vasco Tip/Vascoflange is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system. It serves as an interface between a pacemaker pulse generator and cardiac tissue, facilitating electrical stimulation to regulate heart rhythm in patients requiring cardiac pacing.

This device is supplied as a reusable, sterile medical implant and is classified under FDA product code DTB. It is intended for use in clinical settings by trained healthcare professionals, adhering to sterile procedures for implantation. The device holds FDA 510(k) clearance (K913831) and is regulated under 21 CFR 870.3680, ensuring compliance with Class III medical device standards.

Other devices from Vascor Medical Corp.

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 purpose of the Vasco Tip/Vascoflange device in clinical practice?

    The Vasco Tip/Vascoflange is designed as a permanent pacemaker electrode to serve as the electrical interface between a pacemaker pulse generator and cardiac tissue. Its role is to deliver precise electrical stimulation to regulate heart rhythm in patients who require cardiac pacing, ensuring proper heart function in conditions like bradycardia or heart block.

  • Is the Vasco Tip/Vascoflange intended for single-use or can it be reused?

    The device is explicitly labeled as reusable, meaning it is intended for multiple uses after proper sterilization and maintenance. However, it must be handled under sterile conditions during implantation and subsequent procedures to prevent infection or contamination, as required for medical implants.

  • What types of storage conditions should be followed for the Vasco Tip/Vascoflange?

    While the provided data does not specify exact storage conditions, as a sterile medical implant, it should be stored in a clean, dry environment protected from moisture, dust, and physical damage. The manufacturer’s instructions (not detailed here) should be consulted for precise guidelines, but standard practices for implantable devices apply—such as avoiding extreme temperatures and ensuring packaging integrity until use.

  • How is the regulatory pathway for the Vasco Tip/Vascoflange defined?

    The device holds FDA 510(k) clearance (K913831), classified under product code DTB (Permanent Pacemaker Electrode) and regulated under 21 CFR 870.3680. It was determined substantially equivalent to a predicate device by the FDA’s Cardiovascular (CV) Advisory Committee, adhering to Class III medical device standards. This clearance confirms its compliance with safety and performance requirements for implantation in the cardiovascular system.