DEVICE: RotaLink™ Advancer (08714729317739)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
RotaLink™ Advancer
H80222782001A0
In Commercial Distribution
H80222782001A0
BOSTON SCIENTIFIC CORPORATION
08714729317739
GS1

1
021717889 *Terms of Use
Catheter Advancing Device
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MCX CATHETER, CORONARY, ATHERECTOMY
CLOSE

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 016
P900056 017
P900056 018
P900056 020
P900056 021
P900056 023
P900056 027
P900056 029
P900056 030
P900056 031
P900056 033
P900056 036
P900056 037
P900056 038
P900056 049
P900056 055
P900056 056
P900056 060
P900056 065
P900056 066
P900056 067
P900056 072
P900056 083
P900056 084
P900056 094
P900056 101
P900056 107
P900056 139
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
941a19d8-3734-4a8e-b36c-6362193364e3
May 04, 2021
5
September 24, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE