FDA.reportPublic FDA data

6F Armadillo

Primary DI
00857545008080
Brand
6F Armadillo
Company
Q'APEL MEDICAL LLC
Model
FG 00735-05
Device description
SelectFlex III 064 Neurovascular Access System 105 cm, 30 cm Variable Stiffness, 30cm Coating.
Published
2023-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230322000SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc.2023-06-22QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857545008080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857545008080008575450080808575450080800857545008080

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
020937374
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857545008394ZebraAC6074-095AC6074-0952026-03-05
00857545008400ZebraAC6074-105AC6074-1052026-03-05
00857545008431ZebraAC7087-095AC7087-0952026-03-05
00857545008448ZebraAC7087-105AC7087-1052026-03-05
00857545008158ZebraAC6074-095-30AC6074-095-302025-01-03
00857545008165ZebraAC6074-105-30AC6074-105-302025-01-03
00857545008172ZebraAC6074-115-30AC6074-115-302025-01-03
00857545008189ZebraAC6074-095-20AC6074-095-202025-01-03
00857545008196ZebraAC6074-105-20AC6074-105-202025-01-03
00857545008202ZebraAC6074-115-20AC6074-115-202025-01-03
00857545008219ZebraAC7087-095-20-SAC7087-095-20-S2025-01-03
00857545008226ZebraAC7087-105-20-SAC7087-105-20-S2025-01-03
00857545008233ZebraAC7087-095-20-BAC7087-095-20-B2025-01-03
00857545008240ZebraAC7087-105-20-BAC7087-105-20-B2025-01-03
00857545008257ZebraAC6074-080-30AC6074-080-302025-01-03
00857545008264ZebraAC6074-080-20AC6074-080-202025-01-03
00857545008271ZebraAC7087-080-20-SAC7087-080-20-S2025-01-03
00857545008288ZebraAC7087-080-20-BAC7087-080-20-B2025-01-03
00857545008042ArmadilloFG 00464-05SF7072-105-22-302022-01-16
00857545008059ArmadilloFG 00464-04SF7072-95-22-302022-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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