Identity
- Trade Name
- Rotaglide™ FDA UDI
- Generic Name
- Mechanical atherectomy system, coronary, line-powered FDA UDI
- Device Name
- Lubricant FDA UDI
- Model / Reference
- H7493948300170 FDA UDI
- Description
- Lubricant FDA UDI
Identifiers
- Catalog Number
- H7493948300170 FDA UDI
- Primary DI / UDI-DI
- 00191506005559 FDA UDI
- PMA Number
- P900056 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- Mechanical atherectomy system, coronary, line-powered FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechanical atherectomy system, coronary, line-powered
Rotaglide™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system, coronary, line-powered.
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coroanry — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
- Diamondback Coronary — Cardiovascular Systems, Inc. · Class III
Cleared under the same submission
P900056 also covers:
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
- ROTAPRO™ — Boston Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI b71807b0-637f-4203-bcfd-2e73c5dbf039 35 fields · synced May 31, 2026