SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH— 510(k) K935654
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K935654 for SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH, Substantially Equivalent on 1994-02-22. Applicant: Scimed Life Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Scimed Life Systems, Inc.
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code DQO
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- K254278 — Arterial Pressure Monitoring Set/Tray
- K250751 — DualView Catheter
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
More clearances from Scimed Life Systems, Inc.
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
Source: openFDA MAUDE database, through . 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.