Duns Number:482661753
Device Description: AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 205cm 8cm S AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 205cm 8cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard Contents: 1 guidewire, 1 torquing device and 1 introducer.
Catalog Number
614581
Brand Name
AGILITY
Version/Model Number
614-581
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
K133625
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
3a678c01-c18f-4bbf-853d-2ce20ccbb345
Public Version Date
January 27, 2020
Public Version Number
4
DI Record Publish Date
June 30, 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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |