FDA.reportPublic FDA data

Socrates

Primary DI
00818075011209
Brand
Socrates
Company
SCIENTIA VASCULAR LLC
Model
SC038-156-001
Device description
Socrates 38 Catheter, 156cm working length.
Published
2025-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
NRYCatheter, Thrombus Retriever
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223913000
K242301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223913000Socrates Aspiration SystemScientia Vascular, Inc.2023-09-20NRY
K242301000Socrates 38 CatheterScientia Vascular, Inc.2024-12-04QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818075011209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818075011209008180750112098180750112090818075011209

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Catheter Inner Diameter0.038Inch
Catheter Inner Diameter0.96Millimeter
Catheter Working Length156Centimeter
Outer Diameter0.053Inch
Outer Diameter1.35Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
011234178
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818075010080Plato27BPL273-150-0012016-08-24
00818075011179Aristotle01862A18-200-0012025-08-01
00818075011186Aristotle01863A18-200-0022025-08-01
00818075011193Aristotle01864A18-200-0032025-08-01
00818075011216SocratesSC038-127-0012025-05-27
00818075010059Volo14-200-002V14-200-0022020-03-03
00818075010042Volo14-200-001V14-200-0012020-02-24
00818075010066Volo14-300-001V14-300-0012020-02-24
00818075010073Volo14-300-002V14-300-0022020-02-24
00818075010776SocratesSC038-156-0012023-11-14
00818075010790SocratesTS-254-1102023-11-14
00818075011025SocratesSC038-127-0012023-11-14
00818075010233Aristotle14-200-003Z14-200-0032023-09-25
00818075010240Aristotle14-200-004Z14-200-0042023-09-25
00818075010257Aristotle14-300-003Z14-300-0032023-09-25
00818075010264Aristotle14-300-004Z14-300-0042023-09-25
00818075010455Plato17-160-000PL17-160-0002023-01-26
00818075010462Plato17-160-045PL17-160-0452023-01-26
00818075010479Plato17-160-090PL17-160-0902023-01-26
00818075011018AristotleACL-300-002ACL-300-0022023-04-30

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