FDA.reportPublic FDA data

SurVeil DCB

Primary DI
00812339030548
Brand
SurVeil DCB
Company
Surmodics, Inc.
Model
SRV03513507010
Device description
SurVeil DCB 7.0mm x 100mm x 135cm
Published
2023-10-04
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
ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONUDrug-Eluting Peripheral Transluminal Angioplasty CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210025000SurVeil Drug-Coated BalloonSurmodics,Inc.2023-06-16ONU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812339030548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812339030548008123390305488123390305480812339030548

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, drug-coatedA sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter7Millimeter
Balloon Length100Millimeter
Catheter Length135Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098414659
Device count
1
Combination product
true
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
00812339030753Pounce SheathPFS-0035-12F142023-09-21
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

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