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Jupiter Pta Catheters

by Cordis Corp.

510(k) K970299

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 NumberK970299 Date24 Apr 1997ClearedStatusActive

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  • Withdrawn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)

Full name
Jupiter PTA Catheters (Various)
510(k) Number
FDA product code
LIT
Device class
Class II
Regulation
21 CFR Part 870.1250
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Jupiter Pta Catheters are peripheral transluminal angioplasty catheters. These devices are designed for use in cardiovascular procedures to facilitate the dilation of peripheral vessels.

This device is authorized under FDA 510(k) clearance K970299. It is manufactured by Cordis Corp. and is classified under regulation number 870.1250.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Questions

AI-generated answers, 24 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 clinical use of the Jupiter PTA Catheter?

    The Jupiter PTA Catheter is designed for use in cardiovascular procedures to facilitate the dilation of peripheral vessels through peripheral transluminal angioplasty.

  • What is the regulatory status of the Jupiter PTA Catheter?

    This device is authorized under FDA 510(k) clearance K970299 and is classified under regulation number 870.1250.

  • Who is the manufacturer of the Jupiter PTA Catheter?

    The Jupiter PTA Catheter is manufactured by Cordis Corp., located in Miami Lakes, Florida.