C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 876—GASTROENTEROLOGY-UROLOGY DEVICES › Subpart F—Therapeutic Devices

21 C.F.R. § 876.5130

Urological catheter and accessories

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(a) Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

(b) Classification. (1) Class II (performance standards).

(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]
Notes of Decisions
Cited in 1 case, 1995–1995 · leading case: Dow v. Baxter Healthcare Corp., 899 F. Supp. 822 (D. Mass. 1995).
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Dow v. Baxter Healthcare Corp., 899 F. Supp. 822 (D. Mass. 1995). · cites it 3× “21 C.F.R. § 876.5130 . Finally, Class III includes devices (e.”
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