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AcQCross Qx Integrated Transseptal Dilator/Needle

FDA UDIEUDAMED

Class II (US FDA UDI)

by Acutus Medical, Inc.

Identity

Trade Name
AcQCross Qx Integrated Transseptal Dilator/Needle FDA UDI
Generic Name
Cardiac transseptal access electrosurgical dilator/needle FDA UDI
Model / Reference
900307 FDA UDI

Identifiers

Primary DI / UDI-DI
00850027837574 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac transseptal access electrosurgical dilator/needle

AcQCross Qx Integrated Transseptal Dilator/Needle by Acutus Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Cardiac transseptal access electrosurgical dilator/needle.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acutus Medical, Inc.

Sources (2)

  • FDA UDI 8001c9dd-3777-4f28-b146-d473b7d38aa2 32 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 29, 2026