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Occlusion Balloon Catheter

by Boston Scientific

510(k) K132990

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 · Special NumberK132990 Date22 Oct 2013ClearedStatusActive

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  • Withdrawn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
MJN
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.4450
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.

An occlusion balloon catheter is a device designed to temporarily occlude the ureter during percutaneous nephrolithotomy (PCNL) procedures. It is a compliant balloon catheter used for renal opacification, dislodgment of calculi, and prevention of calculi migration.

This device is supplied sterile and intended for single-use. It is restricted to sale by or on the order of a physician under U.S. federal law. The device has received FDA 510(k) clearance (K132990) and is classified as a Class II medical device under regulation number 870.4450.

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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 intended clinical use of the occlusion balloon catheter?

    The catheter is used during percutaneous nephrolithotomy (PCNL) to temporarily occlude the ureter. By inflating the compliant balloon, the device creates a seal that enables renal opacification, assists in dislodging calculi, and prevents stone fragments from migrating up the urinary tract, thereby improving procedural control and safety.

  • How is the device supplied and what are the sterility requirements?

    The occlusion balloon catheter is supplied sterile and is intended for single‑use only. Because it is pre‑sterilized, it can be opened in the operating room and used immediately, eliminating the need for re‑processing or additional sterilization steps, which helps maintain patient safety and compliance with infection‑control protocols.

  • Can the catheter be reused or reprocessed after a procedure?

    No. The device is explicitly labeled for single‑use. Reuse or reprocessing is not permitted, as the materials and balloon integrity are validated for one-time use only. Reusing could compromise the balloon’s compliance, sterility, and overall performance, potentially leading to procedural complications.

  • What regulatory pathway did the occlusion balloon catheter follow?

    The catheter received FDA 510(k) clearance (K132990) and is classified as a Class II medical device under regulation number 870.4450. This indicates that the device was found substantially equivalent to a legally marketed predicate, allowing it to be marketed in the United States under the specified clearance.