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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 PACING TD CATHETER FDA UDI
Model / Reference
D200F7 FDA UDI
Description
SWAN-GANZ PACING TD CATHETER FDA UDI

Identifiers

Catalog Number
D200F7 FDA UDI
Primary DI / UDI-DI
00690103147315 FDA UDI
510(k) Number
K233983 FDA UDI
K791183 FDA UDI
FDA Product Code
LDF FDA UDI
DYG FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3680 FDA UDI
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:

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 0fff3a8b-b30d-455d-b9dd-f681788f02d7 38 fields · synced Jun 8, 2026