510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122587Substantially Equivalent

Brk Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208

Abbott Medical, Minnetonka MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122587 is the FDA 510(k) clearance record for BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208, a class II device, cleared for St Jude Medical on under FDA product code DRC (Trocar). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K122587.

Clearance record

Decision date
Received
(167 days to decision)
Product code
DRC Trocar
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 14901 Deveau Pl., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRC

Trailing 12 months

FDA records hold no clearances under product code DRC in the trailing twelve months.

FDA records show no clearances under product code DRC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260