INTELLANAV STABLEPOINT™
- Primary DI
- 08714729992233
- Brand
- INTELLANAV STABLEPOINT™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M004RFSDS96200
- Catalog number
- M004RFSDS96200
- Device description
- Ablation Catheter
- Published
- 2024-02-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P150005 | 074 | BLAZER OPEN-IRRIGATED ABLATION CATHETER | Boston Scientific Corp. | 2016-02-24 | OAD |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729992233 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Cardiac radio-frequency ablation system catheter | A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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