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Cathter Passer, Disposable

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Cathter Passer, Disposable FDA UDI
Generic Name
Cerebrospinal fluid shunt valve FDA UDI
Device Name
PASSER 48407 CATHETER 38CM DISP. FDA UDI
Model / Reference
48407 FDA UDI
Description
PASSER 48407 CATHETER 38CM DISP. FDA UDI

Identifiers

Primary DI / UDI-DI
00643169466326 FDA UDI
510(k) Number
K911382 FDA UDI
FDA Product Code
MAJ FDA UDI
GMDN Term
Cerebrospinal fluid shunt valve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cerebrospinal fluid shunt valve

Cathter Passer, Disposable by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebrospinal fluid shunt valve.

Cleared under the same submission

K911382 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI 58432e13-e27e-4e15-8bb6-b725b15bf9a7 35 fields · synced May 30, 2026