ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1— 510(k) K031417

Substantially Equivalent

Intra 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..

Clearance details

Applicant: Intra Luminal Therapeutics, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2003-05-05
Decision date: 2003-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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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, 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.