SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT— 510(k) K030984
Substantially EquivalentIntra Luminal Therapeutics, Inc.
FDA 510(k) clearance K030984 for SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT, Substantially Equivalent on 2003-04-24. Applicant: Intra Luminal Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intra Luminal Therapeutics, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carlsbad, CA, US
Recent devices under product code DQY
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- K041973 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K040481 — SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
- K040037 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.