FDA.reportPublic FDA data

ROTAPRO™

Primary DI
08714729893400
Brand
ROTAPRO™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749393002250
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
08714729893400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729893400087147298934008714729893400

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 Diameter2.25Millimeter

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
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24
00802526488900NA60402014-09-24
00802526488924NA60422014-09-24
00802526488931NA60432014-09-24
00802526496868RELIANCE 4-FRONT™06362018-08-25
00802526496967RELIANCE 4-FRONT™06652018-08-25
00802526496981RELIANCE 4-FRONT™06752018-08-25
00802526497001RELIANCE 4-FRONT™06762018-08-25
00802526523304INGEVITY™ MRI77312016-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506047832AutoElite™BOSTON SCIENTIFIC CORPORATIONMCX2026-09-22
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
08714729893370ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893387ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893394ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11
08714729893417ROTAPRO™BOSTON SCIENTIFIC CORPORATIONMCX2018-07-11