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Tyshak Mini Pediatric Ptv Catheter, Model 107

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003276

by NuMED, Inc.

Identifiers

510(k) Number
K003276 FDA 510(k)
FDA Product Code
LIT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Tyshak Mini Pediatric Ptv Catheter, Model 107 by NuMED, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
NuMED, Inc.

Sources (1)

  • FDA 510(k) K003276 24 fields · synced Jun 18, 2026