FDA.reportPublic FDA data

Pounce Sheath

Primary DI
00812339030753
Brand
Pounce Sheath
Company
Surmodics, Inc.
Model
PFS-0035-12F14
Published
2023-09-21
Public version status
Update
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231828000Pounce™ SheathSurmodics,Inc.2023-09-07DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812339030753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812339030753008123390307538123390307530812339030753

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular catheter sheathA sterile, noninvasive, flexible sleeve intended to be used during cardiovascular catheterization (e.g., femoral, pulmonary) to cover and protect the exposed proximal end of a cardiovascular catheter to prevent contamination (extending the sterile field of the external catheter) and/or to contain a backflow of blood (e.g., during catheter introduction, repositioning or removal). It is typically transparent and includes appropriate connectors for distal attachment to the catheter introducer, and proximal attachment to the extracorporeal portion of the catheter. Neither the catheter nor introduction/procedural devices are included (i.e., not a set). This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098414659
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812339030326Pounce ™ ThrombectomyPTS-0607-7F1352024-10-18
00812339030814Pounce SheathPFS-0035-16F142026-01-26
00812339030784Pounce ™ ThrombectomyPTS-0607-7F1352023-08-16
00812339030302Pounce™ Venous Thrombectomy SystemVTS-1018-090102022-06-22
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
00812339030685Sublime Microcatheter, 035, 90cm, AngleSRA-MC35-ANG0902023-04-14
00812339030692Sublime Microcatheter, 035, 135cm, StraightSRA-MC35-STR1352023-04-14
00812339030708Sublime Microcatheter, 035, 135cm, AngleSRA-MC35-ANG1352023-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226416ARROWTELEFLEX INCORPORATEDDYB2026-08-03
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DYB2026-07-31
06974949033792CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
06974949033808CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-30
10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193121ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193190ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902193206ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196184ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196498ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196511ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
06974949033785CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-07-29
10801902196412ARROWTELEFLEX INCORPORATEDDYB2026-07-29
20801902193470ARROWTELEFLEX INCORPORATEDDYB2026-07-29
10801902189872ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902196436ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902198850ARROWTELEFLEX INCORPORATEDDYB2026-07-28
10801902226409ARROWTELEFLEX INCORPORATEDDYB2026-07-27
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19