ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975— 510(k) K010707

Clearance details

Applicant

Boston Scientific, Target

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

2001-03-09

Decision date

2001-03-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Fremont, CA, US

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• K031049 — GUGLIELMI DETACHABLE COIL (GDC)2003-08-01
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• K022860 — ATLANTIS PV IMAGING CATHETER, MODEL 364562002-11-21
• K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-8152002-10-16

Death

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

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 →