TOP THREE WAY STOPCOCK— 510(k) K832625

Clearance details

Applicant

Top Surgical Manufacturers Co.

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

1983-08-04

Decision date

1983-10-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

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• K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE1985-01-08
• K843415 — TOP HYPODERMIC SYRINGE LUER LOCK1984-12-07
• K843313 — TOP DISPOSABLE SPINAL NEEDLE1984-09-19
• K843414 — TOP HYPODERMIC SYRINGE PISTON1984-09-07
• K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS1984-04-20

Malfunction

770

Total

770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →