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Needle Free Transseptal Cannula

FDA UDI

Class II (US FDA UDI)

by Ppmdm

Identity

Trade Name
Needle Free Transseptal Cannula FDA UDI
Generic Name
Cardiac transseptal needle, single-use FDA UDI
Device Name
89cm Transseptal Cannula Curve 1 FDA UDI
Model / Reference
TSC189 FDA UDI
Description
89cm Transseptal Cannula Curve 1 FDA UDI

Identifiers

Catalog Number
TSC189 FDA UDI
Primary DI / UDI-DI
00858769006173 FDA UDI
510(k) Number
K172934 FDA UDI
FDA Product Code
DRC FDA UDI
GMDN Term
Cardiac transseptal needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1390 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac transseptal needle, single-use

Needle Free Transseptal Cannula by Ppmdm — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal needle, single-use.

Cleared under the same submission

K172934 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ppmdm

Sources (1)

  • FDA UDI 1f44ff83-5391-4f3d-8d40-780a150234ab 35 fields · synced May 31, 2026