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
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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
020937374
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857545008295Lynx Aspiration Catheter SystemAC6072-132-SAC6072-132-S2026-05-29
00857545008301Lynx Aspiration Catheter SystemAC5058-138-SAC5058-138-S2026-05-29
00857545008318Lynx Aspiration Catheter SystemAC5058-149-SAC5058-149-S2026-05-29
00857545008325Lynx Aspiration Catheter SystemAC4044-145-SAC4044-145-S2026-05-29
00857545008332Lynx Aspiration Catheter SystemAC4044-160-SAC4044-160-S2026-05-29
00857545008011WalrusFG 00100-01BG8087-0902021-06-29
00857545008028WalrusFG 00100-02BG8087-0952021-06-29
00857545008004WahooFG 00074SF7072-1052021-06-29
00857545008394ZebraAC6074-095AC6074-0952026-03-05
00857545008400ZebraAC6074-105AC6074-1052026-03-05
00857545008431ZebraAC7087-095AC7087-0952026-03-05
00857545008448ZebraAC7087-105AC7087-1052026-03-05
00857545008097072 Aspiration SystemFG 00806AP6072-1322023-10-11
00857545008103072 Aspiration SystemFG 00995APT-952023-10-11
00857545008127072 Aspiration SystemFG 01252APT6072-1322023-10-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902189452ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902218145ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219692ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20