WATCHMAN FLX™ M635WU50270
GUDID 08714729860501
Left Atrial Appendage Closure Device with Delivery System
BOSTON SCIENTIFIC CORPORATION
Cardiac occluder| Primary Device ID | 08714729860501 |
| NIH Device Record Key | 2f770e5e-ebc5-40ec-917b-77b9b6bd767a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WATCHMAN FLX™ |
| Version Model Number | M635WU50270 |
| Catalog Number | M635WU50270 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
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| Outer Diameter | 27 Millimeter |
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| Outer Diameter | 27 Millimeter |
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| Outer Diameter | 27 Millimeter |
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| Outer Diameter | 27 Millimeter |
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| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08714729860501 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P130013
FDA Product Code
| NGV | System, appendage closure, left atrial |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-05 |
| Device Publish Date | 2020-07-28 |
On-Brand Devices [WATCHMAN FLX™]
| 08714729860525 | Left Atrial Appendage Closure Device with Delivery System |
| 08714729860518 | Left Atrial Appendage Closure Device with Delivery System |
| 08714729860501 | Left Atrial Appendage Closure Device with Delivery System |
| 08714729860495 | Left Atrial Appendage Closure Device with Delivery System |
| 08714729860488 | Left Atrial Appendage Closure Device with Delivery System |
Trademark Results [WATCHMAN FLX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATCHMAN FLX 97459003 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2022-06-15 |
 WATCHMAN FLX 88228883 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2018-12-13 |
 WATCHMAN FLX 87486602 not registered Dead/Abandoned |
Atritech, Inc. 2017-06-13 |
 WATCHMAN FLX 86154069 not registered Dead/Abandoned |
Atritech, Inc. 2013-12-30 |
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