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FlexCath Cross™ Transseptal Solution

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
FlexCath Cross™ Transseptal Solution FDA UDI
Generic Name
Cardiac transseptal access electrosurgical dilator/needle FDA UDI
Device Name
NDL 900307 FLEXCATH CROSS MH 81CM EIFU FDA UDI
Model / Reference
900307 FDA UDI
Description
NDL 900307 FLEXCATH CROSS MH 81CM EIFU FDA UDI

Identifiers

Primary DI / UDI-DI
00763000925147 FDA UDI
510(k) Number
K220047 FDA UDI
FDA Product Code
DYB FDA UDI
DRE FDA UDI
GMDN Term
Cardiac transseptal access electrosurgical dilator/needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
870.1310 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac transseptal access electrosurgical dilator/needle

FlexCath Cross™ Transseptal Solution by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access electrosurgical dilator/needle.

Cleared under the same submission

K220047 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI e8112a4c-17db-497f-aae7-cd0dc7bd4ca7 37 fields · synced May 30, 2026