FDA.reportPublic FDA data

AcQRate Dx Fixed Curve Catheter

Primary DI
04260090928905
Brand
AcQRate Dx Fixed Curve Catheter
Company
VascoMed GmbH
Model
4M 6F 5 mm
Catalog number
460649
Published
2021-10-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201445000MultiCath, AcQRate Dx Fixed Curve CatheterBiotronik, Inc.2021-09-02DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260090928905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260090928905042600909289054260090928905

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
322983446
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260090926529AcQRate Dx Steerable Catheter20/XL/2-8-2mm4606622021-11-24
04260090926536AcQRate Dx Steerable Catheter10/XL/2-10-2mm4606612021-11-24
04260090928974AcQRate Dx Steerable Catheter4/S/5mm4606562021-11-24
04260090928981AcQRate Dx Steerable Catheter4/S/10mm4606572021-11-24
04260090928998AcQRate Dx Steerable Catheter10/S/2-6-2mm4606582021-11-24
04260090929001AcQRate Dx Steerable Catheter10/L/2-6-2mm4606592021-11-24
04260090929018AcQRate Dx Steerable Catheter10/L/2-8-2mm4606602021-11-24
04260090928714AcQRate Dx Fixed Curve Catheter4J Sp 4F 5 mm4606362021-10-22
04260090928721AcQRate Dx Fixed Curve Catheter4J Sp 4F 2-5-2 mm4606372021-10-22
04260090928738AcQRate Dx Fixed Curve Catheter4J Sp 5F 2 mm4606382021-10-22
04260090928745AcQRate Dx Fixed Curve Catheter4J Sp 100 cm 5F 5 mm4606392021-10-22
04260090928752AcQRate Dx Fixed Curve Catheter4J Sp 100 cm 5F 2-5-2 mm4606402021-10-22
04260090928769AcQRate Dx Fixed Curve Catheter4J Sp 5F 2-5-2 mm4606412021-10-22
04260090928776AcQRate Dx Fixed Curve Catheter4C 5F 2-5-2 mm4606422021-10-22
04260090928783AcQRate Dx Fixed Curve Catheter4 HIS 5F 5 mm4606432021-10-22
04260090928851AcQRate Dx Fixed Curve Catheter4J 6F 5 mm4606442021-10-22
04260090928868AcQRate Dx Fixed Curve Catheter4J 6F 5 mm Soft Tip4606452021-10-22
04260090928875AcQRate Dx Fixed Curve Catheter4D 6F 5 mm4606462021-10-22
04260090928882AcQRate Dx Fixed Curve Catheter4C 6F 5 mm4606472021-10-22
04260090928899AcQRate Dx Fixed Curve Catheter4C 6F 5 mm Soft Tip4606482021-10-22

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