Vascotwist 9/60

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K920662 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Vascoscrew 6/60 and Vascoscrew 8/60

  Class III

  FDA 510(k) K914121 Active Cleared 24 Aug 1993

• Vasco Tip/Vascoflange

  Class III

  FDA 510(k) K913831 Active Cleared 25 Aug 1993

• What is the primary purpose of the Vascotwist 9/60 device in clinical practice?

  The Vascotwist 9/60 is designed as an inferior vena cava (IVC) filter to prevent pulmonary embolism by capturing and retaining blood clots within the venous system, thereby reducing the risk of clot migration to the lungs. It is specifically intended for use in cardiovascular procedures where clot prevention is critical.

• Is the Vascotwist 9/60 meant for single-use or can it be reused?

  The Vascotwist 9/60 is explicitly supplied as a single-use, sterile product, meaning it should not be reused after deployment. Sterility and single-use are critical to maintaining safety and functionality, so adherence to these guidelines is mandatory.

• How should the Vascotwist 9/60 be stored to ensure proper functionality?

  Since it is a sterile medical device, the Vascotwist 9/60 must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging, away from contamination, and following manufacturer instructions to preserve sterility until use.

• What regulatory pathway does the Vascotwist 9/60 follow, and how does that affect its use?

  The Vascotwist 9/60 is regulated under the FDA 510(k) clearance process (K920662) and classified as a Class III device under product code DTB. This means it has undergone FDA review to ensure safety and effectiveness, and its use must comply with all applicable FDA guidelines and labeling instructions.