RotaLink™ Plus
- Primary DI
- 08714729316473
- Brand
- RotaLink™ Plus
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H749236310150
- Catalog number
- H749236310150
- Device description
- Pre-Connected Exchangeable Burr Catheter and Burr 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 | 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 |
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 | 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 | 024 | 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 | 036 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 037 | ROTABLATOR(R) | Boston Scientific Corp | 1993-05-28 | MCX |
| P900056 | 049 | 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 | 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 | 104 | 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 |
|---|---|---|---|---|
| 08714729316473 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729316473 | 08714729316473 | 8714729316473 |
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). |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 021717889
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
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| 08714729840442 | SYNERGY™ | H7493926108220 | H7493926108220 | 2016-01-14 |
| 08714729840459 | SYNERGY™ | H7493926108250 | H7493926108250 | 2016-01-14 |
| 08714729840466 | SYNERGY™ | H7493926108270 | H7493926108270 | 2016-01-14 |
| 08714729840473 | SYNERGY™ | H7493926108300 | H7493926108300 | 2016-01-14 |
| 08714729840480 | SYNERGY™ | H7493926108350 | H7493926108350 | 2016-01-14 |
| 08714729840497 | SYNERGY™ | H7493926108400 | H7493926108400 | 2016-01-14 |
| 08714729840503 | SYNERGY™ | H7493926112220 | H7493926112220 | 2016-01-14 |
| 08714729840510 | SYNERGY™ | H7493926112250 | H7493926112250 | 2016-01-14 |
| 08714729840527 | SYNERGY™ | H7493926112270 | H7493926112270 | 2016-01-14 |
| 08714729840534 | SYNERGY™ | H7493926112300 | H7493926112300 | 2016-01-14 |
| 08714729840541 | SYNERGY™ | H7493926112350 | H7493926112350 | 2016-01-14 |
| 08714729840558 | SYNERGY™ | H7493926112400 | H7493926112400 | 2016-01-14 |
| 08714729840565 | SYNERGY™ | H7493926116220 | H7493926116220 | 2016-01-14 |
| 08714729840572 | SYNERGY™ | H7493926116250 | H7493926116250 | 2016-01-14 |
| 08714729840589 | SYNERGY™ | H7493926116270 | H7493926116270 | 2016-01-14 |
| 08714729840596 | SYNERGY™ | H7493926116300 | H7493926116300 | 2016-01-14 |
| 08714729840602 | SYNERGY™ | H7493926116350 | H7493926116350 | 2016-01-14 |
| 08714729840619 | SYNERGY™ | H7493926116400 | H7493926116400 | 2016-01-14 |
| 08714729840626 | SYNERGY™ | H7493926120220 | H7493926120220 | 2016-01-14 |
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