FDA.reportPublic FDA data

Penumbra System

Primary DI
00814548019758
Brand
Penumbra System
Company
PENUMBRA, INC.
Model
PAPS3
Device description
PS Engine Canister Assembly, CE
Published
2021-02-24
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
NRYCATHETER, THROMBUS RETRIEVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180008000Penumbra SystemPenumbra, Inc.2018-06-20NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548019758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548019758008145480197588145480197580814548019758

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
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26