ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE— 510(k) K130766
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K130766 for ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE, Substantially Equivalent on 2013-07-17. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- 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
- Special
- Location
- Bloomington, IN, US
Recent devices under product code DQX
view allMore clearances from Cook, Inc.
view all- K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
- K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
- K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
- K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
- K131772 — CANTATA(R) 2.9 MICROCATHETER
Adverse 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 K130766
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130766.
Data sourced from openFDA. This site is unofficial and independent of the FDA.