510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913312Substantially Equivalent

Helix Shaped Coils with Dacron Fibers, Modified

Target Therapeutics, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913312 is the FDA 510(k) clearance record for HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED, a class II device, cleared for Target Therapeutics on under FDA product code HCG (Device, Neurovascular Embolization). FDA records list 70 510(k) clearances for Target Therapeutics, from to . As of , FDA records show no recalls naming K913312.

Clearance record

Decision date
Received
(106 days to decision)
Product code
HCG Device, Neurovascular Embolization
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Target Therapeutics 130 Rio Robles, San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code HCG

Trailing 12 months
5 clearances under product code HCG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HCG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260