RotaLink™ Advancer
- Primary DI
- 08714729317739
- Brand
- RotaLink™ Advancer
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H80222782001A0
- Catalog number
- H80222782001A0
- Device description
- Catheter Advancing Device
- Published
- 2014-09-24
- 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 |
|---|---|
| MCX | CATHETER, CORONARY, ATHERECTOMY |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| 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 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P900056 | 000 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 001 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 002 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 003 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 004 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 005 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 006 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 008 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 009 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 010 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 011 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 012 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 014 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 015 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 016 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 017 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 018 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 020 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 021 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 023 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 027 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 029 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 030 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 031 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 033 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 036 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 037 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 038 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 049 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 055 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 056 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 060 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 065 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 066 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 067 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 072 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 083 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 084 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 094 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 101 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 107 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 139 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729317739 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729317739 | 08714729317739 | 8714729317739 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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). |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 021717889
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
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| 08714729999577 | ROTAPRO™ | H749394671500 | H749394671500 | 2020-07-01 |
| 08714729999584 | ROTAPRO™ | H749394671750 | H749394671750 | 2020-07-01 |
| 08714729999591 | ROTAPRO™ | H749394672000 | H749394672000 | 2020-07-01 |
| 08714729999607 | ROTAPRO™ | H749394672150 | H749394672150 | 2020-07-01 |
| 08714729999614 | ROTAPRO™ | H749394672250 | H749394672250 | 2020-07-01 |
| 08714729999621 | ROTAPRO™ | H749394672380 | H749394672380 | 2020-07-01 |
| 08714729999638 | ROTAPRO™ | H749394672500 | H749394672500 | 2020-07-01 |
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| 08714729121190 | Ultraflex™ Esophageal NG | M00514200 | 2015-09-24 | |
| 08714729121206 | Ultraflex™ Esophageal NG | M00514210 | 2015-09-24 | |
| 08714729121213 | Ultraflex™ Esophageal NG | M00514220 | 2015-09-24 | |
| 08714729121220 | Ultraflex™ Esophageal NG | M00514230 | 2015-09-24 | |
| 08714729649113 | Ultraflex™ Esophageal NG | M00513750 | 2015-09-24 | |
| 08714729716075 | Ultraflex™ Esophageal NG | M00513850 | 2015-09-24 | |
| 08714729716082 | Ultraflex™ Esophageal NG | M00513860 | 2015-09-24 | |
| 08714729716099 | Ultraflex™ Esophageal NG | M00513840 | 2015-09-24 | |
| 08714729716105 | Ultraflex™ Esophageal NG | M00514240 | 2015-09-24 |
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| 08714729999560 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999577 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999584 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999591 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999607 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999614 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999621 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 08714729999638 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2020-07-01 |
| 10850000491356 | Diamondback Coronary | Cardiovascular Systems, Inc. | MCX | 2020-03-05 |
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| 08714729893387 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2018-07-11 |
| 08714729893394 | ROTAPRO™ | BOSTON SCIENTIFIC CORPORATION | MCX | 2018-07-11 |
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