MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER— 510(k) K023504
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K023504 for MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER, Substantially Equivalent on 2002-11-13. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bloomington, IN, US
Recent devices under product code LIT
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 LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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 K023504
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 K023504.
Data sourced from openFDA. This site is unofficial and independent of the FDA.