IntellaNav StablePoint™ Cable M004RARC040
GUDID 00191506020408
Catheter Cable
BOSTON SCIENTIFIC CORPORATION
Electrical-only medical device connection cable, reusable| Primary Device ID | 00191506020408 |
| NIH Device Record Key | c84889c5-2822-4734-ae33-9b1bdcebfc9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IntellaNav StablePoint™ Cable |
| Version Model Number | M004RARC040 |
| Catalog Number | M004RARC040 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
| Length | 200 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506020408 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P150005
FDA Product Code
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00191506020408]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
Devices Manufactured by BOSTON SCIENTIFIC CORPORATION
| 08714729269779 - Polaris X™ | 2025-02-04 Catheter Cable, Sterile Cable |
| 08714729839835 - Direxion™ HI-FLO™ Transend™-18 System | 2025-01-23 Pre-Loaded Torqueable Microcatheter |
| 08714729269915 - Electrophysiology Cable | 2025-01-15 Sterile Cable |
| 08714729877868 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877875 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877882 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877899 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
| 08714729877905 - Radia™ | 2025-01-08 Bidirectional Steerable Diagnostic Catheter |
Trademark Results [IntellaNav StablePoint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELLANAV STABLEPOINT 90356679 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2020-12-03 |
 INTELLANAV STABLEPOINT 87539785 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2017-07-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.