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Swan-Ganz True Size

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
SWAN-GANZ TRUE SIZE FDA UDI
Generic Name
Pulmonary artery balloon catheter, electrical FDA UDI
Device Name
SWAN-GANZ THERMODILUTION "S" TIP FDA UDI
Model / Reference
151NX7 FDA UDI
Description
SWAN-GANZ THERMODILUTION "S" TIP FDA UDI

Identifiers

Catalog Number
151NX7 FDA UDI
Primary DI / UDI-DI
00690103198584 FDA UDI
510(k) Number
K193466 FDA UDI
FDA Product Code
DYG FDA UDI
DQE FDA UDI
DQO FDA UDI
GMDN Term
Pulmonary artery balloon catheter, electrical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1240 FDA UDI
870.1230 FDA UDI
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulmonary artery balloon catheter, electrical

Swan-Ganz True Size by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary artery balloon catheter, electrical.

Cleared under the same submission

K193466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI beb721a9-ecc8-4305-a018-b2177829fbab 38 fields · synced Jun 8, 2026