FDA.reportPublic FDA data

Indigo

Primary DI
00814548019765
Brand
Indigo
Company
PENUMBRA, INC.
Model
IAPS3
Device description
Ind Engine Canister Assembly, CE
Published
2021-02-19
Public version status
New
Distribution status
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
DXECatheter, embolectomy
QEWPeripheral mechanical thrombectomy with aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180105000
K180412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180105000Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump CanisterPenumbra, Inc.2018-03-08QEW
K180412000Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.2018-05-15QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548019765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548019765008145480197658145480197650814548019765

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration pump, reusableAn electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169723586swiftMATCH Coil, Extra Soft400SWXSFT510-A400SWXSFT5102026-10-01
00810169723593swiftMATCH Coil, Extra Soft400SWXSFT615-A400SWXSFT6152026-10-01
00810169723609swiftMATCH Coil, Soft400SWSFT610-A400SWSFT6102026-10-01
00810169723616swiftMATCH Coil, Soft400SWSFT615-A400SWSFT6152026-10-01
00810169723623swiftMATCH Coil, Soft400SWSFT715-A400SWSFT7152026-10-01
00810169723630swiftMATCH Coil, Soft400SWSFT820-A400SWSFT8202026-10-01
00810169723647swiftMATCH Coil, Standard400SWSTD408-A400SWSTD4082026-10-01
00810169723654swiftMATCH Coil, Standard400SWSTD510-A400SWSTD5102026-10-01
00810169723661swiftMATCH Coil, Standard400SWSTD515-A400SWSTD5152026-10-01
00810169723678swiftMATCH Coil, Standard400SWSTD615-A400SWSTD6152026-10-01
00810169723685swiftMATCH Coil, Standard400SWSTD620-A400SWSTD6202026-10-01
00810169723692swiftMATCH Coil, Standard400SWSTD725-A400SWSTD7252026-10-01
00810169723708swiftMATCH Coil, Standard400SWSTD830-A400SWSTD8302026-10-01
00810169724217Ruby XL Coil SystemRBYPODXL0310-ARBYPODXL03102026-10-01
00810169724224Ruby XL Coil SystemRBYPODXL0320-ARBYPODXL03202026-10-01
00810169724231Ruby XL Coil SystemRBYPODXL0720-ARBYPODXL07202026-10-01
00810169724248Ruby XL Coil SystemRBYPODXL0755-ARBYPODXL07552026-10-01
00810169724255Ruby XL Coil SystemRBYPODXL0830-ARBYPODXL08302026-10-01
00810169724262Ruby XL Coil SystemRBYPODXL0930-ARBYPODXL09302026-10-01
00810169724279Ruby XL Coil SystemRBYPODXL0955-ARBYPODXL0955-A2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00850076916008LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916015LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916022LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916039LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916046LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916053LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916060LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916077LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916084LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916091LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916107LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916114LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916121LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
00850076916855LMI ARTERIAL EMBOLECTOMY CATHETER (EDW)LUCAS MEDICAL INCDXE2026-09-18
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00885403530381Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00885403530398Fogarty CorkscrewBecton, Dickinson And CompanyDXE2026-09-04
00884450466995Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-27
00884450466988Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00884450467008Needle's Eye Snare®Merit Medical Systems, Inc.DXE2026-08-25
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31