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Transseptal Introducer

FDA UDI

Class II (US FDA UDI)

by Ppmdm

Identity

Trade Name
Transseptal Introducer FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
8F x 63cm Transseptal Introducer Set L1 Curve FDA UDI
Model / Reference
TSIL1863 FDA UDI
Description
8F x 63cm Transseptal Introducer Set L1 Curve FDA UDI

Identifiers

Catalog Number
TSIL1863 FDA UDI
Primary DI / UDI-DI
00858769006289 FDA UDI
510(k) Number
K181031 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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: Vascular catheter introduction set, nonimplantable

Transseptal Introducer by Ppmdm — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Cleared under the same submission

K181031 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 ef222998-5341-4859-9929-1ac2aca264dc 35 fields · synced May 29, 2026