Dexterity Steerable Introducer

FDA UDI

Class II (US FDA UDI)

by Primo Medical Group

Identity

Trade Name: Dexterity Steerable Introducer FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: Finished Goods, Steerable Introducer, 14 Fr, 80CM - Dexterity FDA UDI
Model / Reference: 14 Fr x 80 cm FDA UDI
Description: Finished Goods, Steerable Introducer, 14 Fr, 80CM - Dexterity FDA UDI

Identifiers

Catalog Number: 60-0007-25 FDA UDI
Primary DI / UDI-DI: 00864795000139 FDA UDI
510(k) Number: K120086 FDA UDI
FDA Product Code: DRA FDA UDI
DYB FDA UDI
GMDN Term: Cardiac transseptal access set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1280 FDA UDI
870.1340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac transseptal access set

Dexterity Steerable Introducer by Primo Medical Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access set.

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Cook — COOK INCORPORATED · Class II
HeartSpan® — Merit Medical · Class II
HeartSpan® — Merit Medical · Class II
Cook — COOK INCORPORATED · Class II
PathBuilder Transseptal Guiding Introducer — Shanghai Microport Ep Medtech Co., Ltd. · Class II

Cleared under the same submission

K120086 also covers:

Dexterity Steerable Introducer — PRIMO MEDICAL GROUP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Primo Medical Group

Sources (1)

FDA UDI c1b464da-fb17-47c1-ade7-50c052504291 36 fields · synced Jun 8, 2026