FDA.reportPublic FDA data

ROTAPRO™

Primary DI
08714729893370
Brand
ROTAPRO™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749393001750
Device description
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
Published
2018-07-11
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

Product Codes#

Code, Name table
CodeName
MCXCATHETER, CORONARY, ATHERECTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCXCatheter, Coronary, AtherectomyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900056166
P900056174

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900056166ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX
P900056174ROTABLATOR(R)Boston Scientific Corp1993-05-28MCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729893370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729893370087147298933708714729893370

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system, coronary, line-poweredAn assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.75Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506005559Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
00191506005566Rotaglide™BOSTON SCIENTIFIC CORPORATIONMCX2023-11-03
10850026568698Diamondback CoronaryCardiovascular Systems, Inc.MCX2023-06-16
10850026568087Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
10850026568100Diamondback CoronaryCardiovascular Systems, Inc.MCX2021-05-07
08714729996231RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996255RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996248RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729996262RotaWire™ Drive and wireClip™ TorquerBOSTON SCIENTIFIC CORPORATIONMCX2021-02-15
08714729999560ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999577ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999584ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999591ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999607ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999614ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999621ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
08714729999638ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2020-07-01
10850000491356Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10850000491363Diamondback CoronaryCardiovascular Systems, Inc.MCX2020-03-05
10852528005701ViperWireCardiovascular Systems, Inc.MCX2019-09-23
30852528005705Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-09-23
10852528005787Diamondback CoronaryCardiovascular Systems, Inc.MCX2019-02-04
10852528005800Diamondback CoronaryCardiovascular Systems, Inc.MCX2018-07-20
08714729893356ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893363ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893387ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893394ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893400ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893417ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893424ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11