| ASTM F623 -99 (Reapproved 2013) Standard Performance Specification for Foley Catheter |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 9-44 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Tuan Nguyen FDA/OMPT/CDRH/ODE/DRGUD/ULDB/ 301-796-5174 tuan.nguyen2@fda.hhs.gov |
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This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French s 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various s and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification.
| Regulation Number | Device Name | Device Class | Product Code |
| §876.5130 | Accessories, Catheter, G-U | Class 2 | KNY |
| §876.5130 | Adaptor, Ureteral Catheter | Class 1 | EYI |
| §876.5130 | Catheter Care Tray | Class 2 | OHR |
| §876.5130 | Catheter, Coude | Class 2 | EZC |
| §876.5130 | Catheter, Double Lumen Female Urethrographic | Class 2 | FGH |
| §876.5130 | Catheter, Retention Type, Balloon | Class 2 | EZL |
| §876.5130 | Catheter, Straight | Class 2 | EZD |
| §876.5130 | Catheter, Upper Urinary Tract | Class 2 | EYC |
| §876.5130 | Catheter, Ureteral Disposable (X-Ray) | Class 2 | FGF |
| §876.5130 | Catheter, Ureteral, Gastro-Urology | Class 2 | EYB |
| §876.5130 | Catheter, Ureteral, General & Plastic Surgery | Class 2 | GBL |
| §876.5130 | Catheter, Urethral | Class 2 | GBM |
| §876.5130 | Catheter, Urethrographic, Male | Class 2 | FGI |
| §876.5130 | Catheter, Urological | Class 2 | KOD |
| §876.5130 | Catheter, Urological (Antimicrobial) And Accessories | Class 2 | MJC |
| §876.5130 | Connector, Ureteral Catheter | Class 1 | EYK |
| §876.5130 | Holder, Ureteral Catheter | Class 1 | EYJ |
| §876.5130 | Kit, Catheter, External, Male (Excludes Hiv Testing) | Class 2 | NWQ |
| §876.5130 | Kit, Catheter, Foley (Excludes Hiv Testing) | Class 2 | NWR |
| §876.5130 | Kit, Catheter, Urinary (Exludes Hiv Testing) | Class 2 | NWO |
| §876.5130 | Stylet For Catheter, Gastro-Urology | Class 1 | EZB |
| §876.5130 | Stylet, Ureteral | Class 1 | EYA |
| §876.5130 | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | FCM |
| Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters, Issued prior to February 1997. |