GUNTHER TULIP VENA CAVA FILTER SET— 510(k) K043509
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K043509 for GUNTHER TULIP VENA CAVA FILTER SET, Substantially Equivalent on 2005-05-05. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code DTK
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bloomington, IN, US
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More 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 DTK
product code DTK- Death
- 208
- Injury
- 11,286
- Malfunction
- 3,002
- Total
- 14,496
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.