510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K043401Substantially Equivalent

Spectranetics Lld Cs, Model 518-039

Spectranetics Corp., Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043401 is the FDA 510(k) clearance record for SPECTRANETICS LLD CS, MODEL 518-039, a class II device, cleared for Spectranetics Corp. on under FDA product code DRB (Stylet, Catheter). FDA records list 57 510(k) clearances for Spectranetics Corp., from to . As of , FDA records show no recalls naming K043401.

Clearance record

Decision date
Received
(96 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectranetics Corp. 96 Talamine Ct., Colorado Springs CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRB

Trailing 12 months

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

FDA records show no clearances under product code DRB in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, 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