FDA.reportPublic FDA data

Perfect-O

Primary DI
00860014796807
Brand
Perfect-O
Company
BALOSMARK, INC.
Model
FA12913
Device description
Ostial Positioning Catheter
Published
2026-06-19
Public version status
Update
Distribution status
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260289000Perfect-O Ostial Positioning CatheterBalosmark, Inc.2026-06-05DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014796807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014796807008600147968078600147968070860014796807

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
144849021
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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