FDA.reportPublic FDA data

Bipolar 5FR 110cm Modified-J Shrouded Pins

Primary DI
M8226521110P0
Brand
Bipolar 5FR 110cm Modified-J Shrouded Pins
Company
ALPHA MEDICAL INSTRUMENTS
Model
652/1-110P
Catalog number
625/1-110P
Device description
Bipolar Balloon Pacing Catheter
Published
2016-10-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDFElectrode, Pacemaker, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930069000BIPOLAR BALLOON PACING CATHETER BY J-LLOYDJ-Lloyd Medical, Inc.1994-01-28LDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M8226521110P0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
949-460-0944info@alphamedicalinstruments.com

Regulatory Flags#

DUNS number
627767577
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M822162110PS2Wedge Pressure 6fr 110cm S-tip 162-110PS162-110PS2016-11-10
M82214260P2Wedge Pressure 4fr 60cm Modified J-tip 142-60P142-60P2016-11-10
M822152110P0Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip)152-110P152-110P2016-10-08
M82215260P2Wedge Pressure 5fr 60cm Modified J-tip 152-60P152-60P2016-11-10
M822162110PS0Wedge Pressure  6fr 110cm S-tip162-110PS162-110PS2016-10-08
M82216280P0Wedge Pressure  6fr 110cm Standard Tip162-80P162-80P2016-10-08
M82216280P2Wedge Pressure  6fr 80cm Modified J-tip162-80P162-80P2016-10-08
M822172110PS2Wedge Pressure 7fr 110cm S-tip172-110PS172-110PS2016-11-10
M82217290P2Wedge Pressure 7fr 90cm Modified J-tip 172-90P172-90P2016-11-10
M82225280P2Angiographic 5fr 80cm C-tip252-80P252-80P2016-11-10
M822474110P0Thermodilution 7FR 110cm Modified J-tip474-110P474-110P2016-10-08
M822606002Bipolar 5FR 110cm Modified-J Shrouded Pins606002652/1-110P2017-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
10801902216110ARROWTELEFLEX INCORPORATEDLDF2023-07-14
10801902198386ARROWTELEFLEX INCORPORATEDLDF2022-11-18
08718627412701MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2016-04-25
08718627411674MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411698MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411711MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411735MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411759MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411773MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411797MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411810MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411834MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411858MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411872MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411896MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411919MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411933MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411957MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411971MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411995MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412015MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412039MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412053MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412077MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412091MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412114MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412138MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412152MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412176MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11