WATCHDOG Hemostasis Valve Kit— 510(k) K172453
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K172453 for WATCHDOG Hemostasis Valve Kit, Substantially Equivalent on 2017-11-09. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code DQX
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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 K172453
K-number listed on FDA's recall record- Z-1592-2023 — WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
- Z-1593-2023 — WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172453.
Data sourced from openFDA. This site is unofficial and independent of the FDA.