Skip to content

PeriVac Kit

by Boston Scientific

510(k) K032050

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK032050 Date8 Aug 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0071-04 FDA Unclassified (pre-2012) initiated 29 Sep 2003

    The product has the potential to break during withdrawal process.

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  • Withdrawn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
DQX
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1330
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The PeriVac Kit is a pericardial drainage set designed for the aspiration of pericardial fluid. It includes components such as an 8.3 French Straight or Flexima Pigtail drainage catheter with side holes, enabling effective fluid removal during pericardial drainage procedures. This device is intended for use in clinical settings where pericardial effusion requires intervention to relieve pressure on the heart.

The kit is supplied as a pre-assembled system, containing all necessary components for pericardial drainage in a single package. It is intended for single-use and must be handled under sterile conditions. The device is classified under product code DQX and has received FDA 510(k) clearance as substantially equivalent through the traditional review pathway. Storage and handling should comply with standard medical device protocols to ensure sterility and functionality.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Questions

AI-generated answers, 1 Oct 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 PeriVac Kit used for?

    The PeriVac Kit is designed specifically for the aspiration of pericardial fluid in clinical settings where pericardial effusion requires intervention. It helps relieve pressure on the heart by effectively draining excess fluid, which is critical in managing conditions like cardiac tamponade or post-surgical effusion.

  • How is the PeriVac Kit supplied, and what components does it include?

    The PeriVac Kit is supplied as a pre-assembled, single-use system in a sterile package. It includes an 8.3 French Straight or Flexima Pigtail drainage catheter with side holes, along with all necessary components required for pericardial drainage procedures. This ensures ease of use and minimizes the risk of contamination during setup.

  • Is the PeriVac Kit intended for single-use or reuse?

    The PeriVac Kit is strictly intended for single-use only. This design ensures patient safety by preventing cross-contamination between procedures, as well as maintaining sterility and functionality for the intended clinical application.

  • What storage and handling precautions should be taken with the PeriVac Kit?

    The PeriVac Kit must be stored and handled according to standard medical device protocols to preserve sterility and functionality. It should be kept in its original packaging until ready for use, protected from physical damage, extreme temperatures, and contamination. Always follow manufacturer guidelines for unpacking and preparing the kit under aseptic conditions.

  • What regulatory pathway was used for the FDA clearance of the PeriVac Kit?

    The PeriVac Kit received FDA 510(k) clearance through the traditional review pathway, demonstrating substantial equivalence to a legally marketed predicate device. This clearance was granted under product code DQX and was reviewed by the Cardiovascular (CV) Advisory Committee.