FDA.reportPublic FDA data

ReverseTM

Primary DI
00847536021945
Brand
ReverseTM
Company
Reverse Medical Corporation
Model
MIC-021-150
Device description
MICROCATHETER MIC-021-150 REVERSE
Published
2016-09-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCATHETER, PERCUTANEOUS
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122684000REVERSE MEDICAL MICROCATHETERReverse Medical Corporation2012-12-07DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536021945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536021945008475360219458475360219450847536021945

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage. Store under controlled room temperature

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
963324913
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536003552ReverseTMMIC-021-1502016-08-19
00847536003569ReverseTMMIC-027-1502016-08-12
00847536020825MVP®MVP-7Q2019-08-01
00847536004009MVP®MVP-9Q2015-10-23
00847536003835N/ARMCS-2.75US2015-09-15
00847536003873N/AED2-RM-US2015-10-23
00847536003583MVP®MVP-3US2015-09-11
00847536003606MVP®MVP-5US2015-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
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
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16