Flextra Steerable Introducer

FDA UDI

Class II (US FDA UDI)

by Rhythm Xience, Inc.

Identity

Trade Name: Flextra Steerable Introducer FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F FDA UDI
Model / Reference: 122851 FDA UDI
Description: Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F FDA UDI

Identifiers

Primary DI / UDI-DI: 00852392007002 FDA UDI
510(k) Number: K170373 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Cardiac transseptal access set 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Cardiac transseptal access set

Flextra Steerable Introducer by Rhythm Xience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

K170373 also covers:

Flextra Steerable Introducer — RHYTHM XIENCE, INC.

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: Rhythm Xience, Inc.

Sources (1)

FDA UDI f04fd526-fd63-4112-b209-923ddc63d036 34 fields · synced Jun 8, 2026