Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)
FDA 510(k) K021864 · Primeline Medical Products, Inc.
510(k) numberK021864
Submission
- Device name
- Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)
- Applicant
- Primeline Medical Products, Inc.
Edmonton, Alberta, CA - Received
- June 6, 2002
- Decision date
- September 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K023266 | Primagard Surgical GownsFYA · Traditional | 11/08/2002SE |
| K023117 | Primagard Surgical GownsKKX · Traditional | 11/08/2002SE |
| K022868 | Primagard Surgical Equipment DrapesKKX · Traditional | 11/08/2002SE |
| K021076 | Primagard Yellow Surgical Mask, Pleated, Tie-On, PM4-307; Primagard Yellow Surgical…FXX · Special | 04/16/2002SE |
| K011789 | Procedure Masks: PM4-301 and PM4-304FXX · Special | 06/22/2001SE |
| K001951 | Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask…FXX · Traditional | 09/08/2000SE |
| K971076 | Primed Shoe Covers, Primed Head CoversFXP · Traditional | 01/13/1998SE |
| K971075 | Primed Prime-Plus Cotton Gauze SpongesEFQ · Traditional | 06/22/1997SE |
Questions and answers
When was Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142) cleared by the FDA?
Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142) (K021864) received a 510(k) decision of Substantially Equivalent on September 23, 2002, 109 days after the submission was received.
What is the product code of K021864?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.