SEEKER CROSSING SUPPORT CATHETER— 510(k) K103367
Substantially EquivalentBard Peripheral Vascular, Inc.
FDA 510(k) clearance K103367 for SEEKER CROSSING SUPPORT CATHETER, Substantially Equivalent on 2010-12-08. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Peripheral Vascular, 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
- Tempe, AZ, US
Recent devices under product code DQY
view allMore clearances from Bard Peripheral Vascular, Inc.
view allAdverse 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 →
Recalls naming K103367
K-number listed on FDA's recall record- Z-1802-2018 — BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
- Z-1803-2018 — BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.