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6F Armadillo

FDA UDI

Class II (US FDA UDI)

by Q’Apel Medical, Inc.

Identity

Trade Name
6F Armadillo FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
SelectFlex III 064 Neurovascular Access System 105 cm, 30 cm Variable Stiffness, 30cm Coating. FDA UDI
Model / Reference
FG 00735-05 FDA UDI
Description
SelectFlex III 064 Neurovascular Access System 105 cm, 30 cm Variable Stiffness, 30cm Coating. FDA UDI

Identifiers

Primary DI / UDI-DI
00857545008080 FDA UDI
510(k) Number
K230322 FDA UDI
FDA Product Code
QJP FDA UDI
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Vascular guide-catheter, single-use

6F Armadillo by Q’Apel Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Q’Apel Medical, Inc.

Sources (1)

  • FDA UDI 1f37ae7d-6be2-4c1f-9159-d1b500da54db 34 fields · synced May 30, 2026