AccessGUDID - DEVICE: Pronto® XL extraction catheter (M20650900)

GUDID

Device Identifier (DI) Information

Brand Name: Pronto® XL extraction catheter
Version or Model: 5090
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20650900
Issuing Agency: HIBCC
Commercial Distribution End Date: December 02, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The 14F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system and to infuse/deliver diagnostic or therapeutic agents.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112571	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 14 French
Device Size Text, specify: Straight Tip

Device Record Status

Public Device Record Key: 377de595-71db-4c17-a2b4-bc29f4e9ae2f
Public Version Date: November 09, 2022
Public Version Number: 6
DI Record Publish Date: September 05, 2016