FDA.reportPublic FDA data

Pounce ™ Thrombectomy

Primary DI
00812339030784
Brand
Pounce ™ Thrombectomy
Company
Surmodics, Inc.
Model
PTS-0607-7F135
Device description
Pounce Arterial Packaged Assembly, Sterile
Published
2023-08-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220501000Pounce Thrombectomy SystemSurmodics,Inc.2022-03-23QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812339030784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812339030784008123390307848123390307840812339030784

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
098414659
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812339030807Pounce ™ XL ThrombectomyPTS-1011-7F1352024-11-13
00812339030760Pounce ™ LP ThrombectomyPTS-0407-7F1502024-03-19
00812339030319Pounce Venous Thrombectomy SystemVTS-0018-090102023-10-27
00812339030302Pounce™ Venous Thrombectomy SystemVTS-1018-090102022-06-22
00812339030326Pounce ™ ThrombectomyPTS-0607-7F1352024-10-18
00812339030814Pounce SheathPFS-0035-16F142026-01-26
00812339030753Pounce SheathPFS-0035-12F142023-09-21
00812339030555Sublime Microcatheter, 014, 65cm, StraightSRA-MC14-STR0652023-04-14
00812339030562Sublime Microcatheter, 014, 65cm, AngleSRA-MC14-ANG0652023-04-14
00812339030579Sublime Microcatheter, 014, 150cm, StraightSRA-MC14-STR1502023-04-14
00812339030586Sublime Microcatheter, 014, 150cm, AngleSRA-MC14-ANG1502023-04-14
00812339030593Sublime Microcatheter, 014, 200cm, StraightSRA-MC14-STR2002023-04-14
00812339030609Sublime Microcatheter, 014, 200cm, AngleSRA-MC14-ANG2002023-04-14
00812339030616Sublime Microcatheter, 018, 65cm, StraightSRA-MC18-STR0652023-04-14
00812339030623Sublime Microcatheter, 018, 65cm, AngleSRA-MC18-ANG0652023-04-14
00812339030630Sublime Microcatheter, 018, 150cm, StraightSRA-MC18-STR1502023-04-14
00812339030647Sublime Microcatheter, 018, 150cm, AngleSRA-MC18-ANG1502023-04-14
00812339030654Sublime Microcatheter, 018, 200cm, StraightSRA-MC18-STR2002023-04-14
00812339030661Sublime Microcatheter, 018, 200cm, AngleSRA-MC18-ANG2002023-04-14
00812339030678Sublime Microcatheter, 035, 90cm, StraightSRA-MC35-STR0902023-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
00860008103819Recana Debulking CatheterIntervene, Inc.QEW2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.QEW2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.QEW2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.QEW2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXInari Medical, Inc.QEW2026-01-06
00810123710256Artix AXInari Medical, Inc.QEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722497Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722503Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722510Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722558Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24