PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290— 510(k) K864153

Clearance details

Applicant

Pace Medical

Product code

Code DTB

Device class

Class 3

Regulation

21 CFR 870.3680

Advisory panel

Cardiovascular

Date received

1986-10-23

Decision date

1987-01-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waltham, MA, US

• K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS2006-07-10
• K041809 — PERMANENT PACING LEAD, MODEL PY22004-08-06
• K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU2004-04-07
• K031274 — MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
• K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD2003-05-16

• K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 48252001-09-12
• K012392 — DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 42602001-09-04
• K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V2000-10-18
• K002496 — MODEL 4815 ADAPTER2000-10-10
• K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER2000-10-10

Death

1,491

Injury

67,311

Malfunction

79,368

Other

10

Total

148,180

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →