Duns Number:020198912
Device Description: Diagnostic EP Catheter, Cournand curve, 10 electrodes, 2-2-2-20-2-2-2-2-2mm spacing, 6F.
Catalog Number
6FMC00684
Brand Name
N/A
Version/Model Number
N/A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 2016
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K012708
Product Code
NLH
Product Code Name
CATHETER, RECORDING, ELECTRODE, REPROCESSED
Public Device Record Key
3bf3917a-aabb-48c0-9aa0-b1b71617f2bc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |