Duns Number:076769355
Device Description: A long flexible tube with an inflatable balloon at its distal tip used to dilate gastroint A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
Catalog Number
3302
Brand Name
Hobbs Achalasia Dilation Balloon
Version/Model Number
3302
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K834413
Product Code
KNQ
Product Code Name
Dilator, Esophageal
Public Device Record Key
09c0983a-d1ed-436a-8a5d-78d5c917390a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |