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Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 9-44: ASTM F623 -99 (Reapproved 2013), standard performance specification for foley catheter. (ObGyn/Gastroenterology)

Date of Standard: 1999. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Urological Catheters
Processes Affected:
510(K), Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard and any annexes.
Related CFR Citations and Product Codes:
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 (Kit) 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
Relevant Guidance:
Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters. This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practice GGP's.
FDA Technical Contact:
 Tuan Nguyen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G223
  Silver Spring MD 20993
  301/796-5174
  email: tuan.nguyen2@fda.hhs.gov
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