510(k) K890471

PMS ANGIO DRAPE by Professional Medical Services — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 27, 1989
Date Received: January 31, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Professional Medical Services

K913094 — DISPOSABLE SLIDE VALVE MANIFOLD (January 27, 1992)
K910378 — PRESSURE MONITORING EXTENSION LINE (April 22, 1991)
K904508 — CONDOR ANALOG INFLATION SYRINGE (April 2, 1991)
K904954 — CONDOR DIGITAL INFLATION SYRINGE (January 16, 1991)
K902606 — RADIOPAQUE RULER (September 27, 1990)
K884577 — PROCEDURE READY TRAYS (August 1, 1989)
K884497 — CONTROL SYRINGE (December 12, 1988)
K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
K864555 — 3 RING ATTACHMENT (December 1, 1986)
K854941 — PMS PERCUTANEOUS PUNCTURE NEEDLE (April 16, 1986)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)