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Swan-Ganz

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
SWAN-GANZ FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
SWAN-GANZ BIPOLAR PACING CATHETER FDA UDI
Model / Reference
D97120F5 FDA UDI
Description
SWAN-GANZ BIPOLAR PACING CATHETER FDA UDI

Identifiers

Catalog Number
D97120F5 FDA UDI
Primary DI / UDI-DI
00690103150421 FDA UDI
510(k) Number
K233983 FDA UDI
K822723 FDA UDI
FDA Product Code
DYG FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1240 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: Temporary cardiac pacing balloon catheter

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

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Cleared under the same submission

K233983 also covers:

K822723 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 52b067dc-1652-4d51-98be-8d0ed60f297e 38 fields · synced Jun 6, 2026