ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1— 510(k) K031417
Substantially EquivalentIntra Luminal Therapeutics, Inc.
FDA 510(k) clearance K031417 for ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1, Substantially Equivalent on 2003-07-11. 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
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code DQY
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- K050915 — SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
- 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.