FDA.reportPublic FDA data

ACCLARENT PIVOT

Primary DI
20705031465579
Brand
ACCLARENT PIVOT
Company
ACCLARENT, INC.
Model
PVT0616L
Catalog number
PVT0616L
Device description
ACCLARENT PIVOT Illumination Balloon Dilation System
Published
2020-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNZEustachian tube balloon dilation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNZEustachian Tube Balloon Dilation DeviceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201115000Next Generation Balloon Dilation SystemAcclarent, Inc.2020-08-27LRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031465579PackageGS15In Commercial Distribution
10705031465572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146557920705031465579
1070503146557210705031465572

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, single-useA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)687-5888xxx@xxx.xxx
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
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
10705031063549RELIEVA SIDEKICK LPSDKKLPSDKKLP2016-10-01
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01
10705031200289RELIEVA ULTIRRABC0716RUBC0716RU2016-10-01
10705031200296RELIEVA ULTIRRABC0724RUBC0724RU2016-10-01
10705031205871RELIEVA VORTEX 2RV02RV022016-10-01
10705031237087ACCLARENT NAVWIREGW35150NZGW35150NZ2017-08-01
10705031238701RELIEVA ULTIRRA NAVBC0516RUNBC0516RUN2017-08-01
10705031241008RELIEVA SPINPLUS NAVRSP0516MFSNRSP0516MFSN2018-02-09
10705031241015RELIEVA SPINPLUS NAVRSP0616MFSNRSP0616MFSN2018-02-18
10705031245907TruDi NAVWIRETDNW001TDNW0012019-10-20
10705031462588RELIEVA TRACTRT1040ART1040A2019-05-31
10705031462601RELIEVA TRACTRT1240ART1240A2019-05-31
10705031462625RELIEVA TRACTRT1440ART1440A2019-05-31
10705031462649RELIEVA TRACTRT1640ART1640A2019-05-31
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931680VenSure 4D Balloon Dilation SystemFiagon GmbHPNZ2025-09-18
04250676745088TubaVent® balloon dilatation systemSpiggle & Theis Medizintechnik GmbHPNZ2025-02-27
04250676743473Inflation deviceSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743503TubaVent® shortSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743510TubaVent® short wideSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743527TubaInsert® - Type 45°Spiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04260759931246VenSure Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931260VenSure Nav Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931253VenSure Light Balloon Dilation SystemFiagon GmbHPNZ2022-10-14
00850002250428Audion STRYKER CORPORATIONPNZ2022-06-03
00763000416034NuVentMEDTRONIC XOMED, INC.PNZ2021-10-04
10705031465565ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465572ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465596ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465586ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465609ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465616ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
00857326005000XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005017XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005024XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005031XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005048XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005055XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005062XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005079XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005116XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005123XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005130XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005147XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
10705031230880ACCLARENT AERAACCLARENT, INC.PNZ2016-11-17