DEVICE: RotaLink™ Plus (08714729228363)

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Device Record History
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Device Identifier (DI) Information
RotaLink™ Plus
H749236310030
In Commercial Distribution
H749236310030
BOSTON SCIENTIFIC CORPORATION
08714729228363
GS1

1
021717889 *Terms of Use
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61205 Mechanical atherectomy system, coronary, line-powered
An 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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MCX CATHETER, CORONARY, ATHERECTOMY
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P900056 000
P900056 001
P900056 002
P900056 003
P900056 004
P900056 005
P900056 006
P900056 008
P900056 009
P900056 010
P900056 011
P900056 012
P900056 014
P900056 015
P900056 017
P900056 018
P900056 020
P900056 021
P900056 023
P900056 024
P900056 027
P900056 029
P900056 036
P900056 037
P900056 049
P900056 056
P900056 060
P900056 065
P900056 066
P900056 067
P900056 083
P900056 084
P900056 094
P900056 101
P900056 104
P900056 107
P900056 139
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 0.059 in Diameter
Device Size Text, specify: 1.50 mm Diameter
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Device Record Status
85315f8f-0dba-4f09-a867-c4d1619ce22b
April 06, 2021
5
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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