Duns Number:020198912
Device Description: Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM),8 electrodes, 2.5-4-2. Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM),8 electrodes, 2.5-4-2.5-2.5-2.5-2.5-2.5mm spacing, 6F
Catalog Number
D608DR002CT
Brand Name
N/A
Version/Model Number
N/A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
440ea4a9-c1be-470f-828e-6701a23df238
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 |