Cook filter 510(k) nod
This article was originally published in The Gray Sheet
Executive Summary
Cook's Günther Tulip vena cava filter receives 510(k) clearance for use on a removable basis. Originally designed for both temporary and permanent use, the device captures blood clots before they can reach the lungs, causing a pulmonary embolism. Competitors include Cordis, B. Braun and Bard (1"The Gray Sheet" Aug. 18, 2003, p. 18)...
You may also be interested in...
Retrievable Vena Cava Filter Claim Sought By Cook; Bard First To U.S. Market
Cook, Inc. is seeking 510(k) clearance for removable use of its Günther Tulip MReye vena cava filter
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.