Duns Number:068966261
Device Description: Deflectable Sheath
Catalog Number
18-3356
Brand Name
HeartLight
Version/Model Number
18-3356
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
K152310
Product Code
DRA
Product Code Name
CATHETER, STEERABLE
Public Device Record Key
465bb933-2c31-42c4-9621-739e48b7c3d5
Public Version Date
March 05, 2020
Public Version Number
4
DI Record Publish Date
June 15, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
3 | A medical device with high risk that requires premarket approval | 11 |