Duns Number:021717889
Device Description: Access Sheath with Dilator
Catalog Number
M635TU10060
Brand Name
WATCHMAN® Access System
Version/Model Number
M635TU10060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P130013,P130013,P130013,P130013,P130013,P130013
Product Code
NGV
Product Code Name
System, appendage closure, left atrial
Public Device Record Key
1c06a9b8-84c6-47d4-b10d-9548d11e3d08
Public Version Date
February 19, 2021
Public Version Number
6
DI Record Publish Date
March 20, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |