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KEYST0NE Medical Picc Catheter

by Keystone Medical

510(k) K011860

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 NumberK011860 Date27 Jun 2001ClearedStatusActive

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  • Withdrawn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
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Keystone Medical PICC Catheter is a Peripherally Inserted Central Catheter (PICC), a long-term intravascular access device designed for central venous access. It is intended for administration of fluids, medications, parenteral nutrition, and blood products, as well as for monitoring central venous pressure and drawing blood samples.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K011860) and falls under the product code FOZ, classified under the General Hospital category. The catheter is manufactured by Keystone Medical and must be handled and stored according to sterile medical device protocols.

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