510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993434Substantially Equivalent

Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a

BIOTRONIK AG, Lake Oswego OR / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993434 is the FDA 510(k) clearance record for PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A, a class III device, cleared for Biotronik, Inc. on under FDA product code DXY (Implantable Pacemaker Pulse-Generator). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K993434.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DXY Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Applicant
Biotronik, Inc. 6024 Jean Rd., Lake Oswego OR
510(k) summary
Summary
Third party review
No

Clearances, product code DXY

Trailing 12 months

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

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