FDA.reportPublic FDA data

AcQRate Dx Fixed Curve Catheter

Primary DI
04260090928783
Brand
AcQRate Dx Fixed Curve Catheter
Company
VascoMed GmbH
Model
4 HIS 5F 5 mm
Catalog number
460643
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
04260090928783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260090928783042600909287834260090928783

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
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
04260090928905AcQRate Dx Fixed Curve Catheter4M 6F 5 mm4606492021-10-22

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00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
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06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
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