PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING— 510(k) K952206

Unknown

Pacesetter, Inc.

FDA 510(k) clearance K952206 for PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING, Unknown on 1995-08-31. Applicant: Pacesetter, Inc..

Clearance details

Applicant: Pacesetter, Inc.
Product code: Code DTB
Advisory panel: Cardiovascular
Date received: 1995-05-10
Decision date: 1995-08-31
Decision: Unknown
Clearance type: Traditional
Location: Sylmar, CA, US

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Adverse events under product code DTB

product code DTB

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.