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Sapphire II PRO

by Orbusneich Medical, Inc.

510(k) K163114

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 NumberK163114 Date5 Jan 2017ClearedStatusActive

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  • Withdrawn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
LOX
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Sapphire II PRO is a semi-compliant percutaneous transluminal coronary angioplasty balloon catheter. It is designed for use in coronary interventions to facilitate balloon angioplasty.

This device is authorized for sale in the USA under FDA 510(k) clearance. Federal law restricts this device to sale by or on the order of a physician. It is available in sizes ranging from 1.0 mm to 4.0 mm.

Other devices from Orbusneich Medical, Inc.

  • Sapphire

    Class II

  • Sapphire Nc

    Class II

  • Sapphire NC Plus

    Class II

Questions

AI-generated answers, 26 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 Sapphire II PRO used for?

    The Sapphire II PRO is a semi-compliant percutaneous transluminal coronary angioplasty balloon catheter designed for use in coronary interventions to facilitate balloon angioplasty.

  • What size options are available for this catheter?

    The Sapphire II PRO is available in a range of sizes from 1.0 mm to 4.0 mm to accommodate different clinical requirements during coronary interventions.

  • Is this device available for direct purchase?

    No, federal law restricts this device to sale by or on the order of a physician. It is authorized for sale in the USA under FDA 510(k) clearance.