FDA.reportPublic FDA data

Penumbra System

Primary DI
00815948020030
Brand
Penumbra System
Company
PENUMBRA, INC.
Model
PMXENGN
Device description
Penumbra ENGINE
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00815948020030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948020030008159480200308159480200300815948020030

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815948025134BenchmarkBMK6F95M-A2023-01-05
00815948025141BenchmarkBMK6F105-A2023-01-05
00815948025158BenchmarkBMK6F105M-A2023-01-05
00815948025165BenchmarkBMK6F115-A2023-01-05
00815948025172BenchmarkBMK6F115M-A2023-01-05
00815948025189BenchmarkBMK6F95BER120-A2023-01-05
00815948025196BenchmarkBMK6F95SIM120-A2023-01-05
00815948025202BenchmarkBMK6F95MBER120-A2023-01-05
00815948025219BenchmarkBMK6F95MSIM120-A2023-01-05
00815948025226BenchmarkBMK6F105BER130-A2023-01-05
00815948025233BenchmarkBMK6F105SIM130-A2023-01-05
00815948025240BenchmarkBMK6F105MBER130-A2023-01-05
00815948025257BenchmarkBMK6F105MSIM130-A2023-01-05
00815948022553Indigo SystemLITNG12HTORQ100-A2020-07-15
00815948022560Indigo SystemLITNG12XTORQ100-A2020-07-15
00815948022577Indigo SystemLITNG12HTORQ115-A2020-07-15
00815948022591Indigo SystemLITNG12XTORQ115-A2020-07-15
00815948022904Indigo SystemLITNG12HTORQ1002020-07-15
00815948022911Indigo SystemLITNG12XTORQ1002020-07-15
00815948022928Indigo SystemLITNG12HTORQ1152020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10886704086475CEREGLIDECerenovus, Inc.NRY2025-09-26