PMS Angio Drape
FDA 510(k) K890471 · Professional Medical Services
510(k) numberK890471
Submission
- Device name
- PMS Angio Drape
- Applicant
- Professional Medical Services
North Salt Lake, UT, US - Received
- January 31, 1989
- Decision date
- February 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
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 510(k)s with product code KKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
More from Whitney Medical Solutions
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|---|---|---|
| K913094 | Disposable Slide Valve ManifoldDQO · Traditional | 01/27/1992SE |
| K910378 | Pressure Monitoring Extension LineDQO · Traditional | 04/22/1991SE |
| K904508 | Condor Analog Inflation SyringeMAV · Traditional | 04/02/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | 01/16/1991SE |
| K902606 | Radiopaque RulerKPR · Traditional | 09/27/1990SE |
| K884577 | Procedure Ready TraysFOZ · Traditional | 08/01/1989SESD |
| K884497 | Control SyringeFMF · Traditional | 12/12/1988SE |
| K872448 | Blood Containment PackLRO · Traditional | 11/17/1987SE |
| K864555 | 3 Ring AttachmentFMF · Traditional | 12/01/1986SE |
| K854941 | PMS Percutaneous Puncture NeedleDYB · Traditional | 04/16/1986SE |
Questions and answers
When was PMS Angio Drape cleared by the FDA?
PMS Angio Drape (K890471) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 27 days after the submission was received.
What is the product code of K890471?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.