MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210— 510(k) K020765
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K020765 for MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210, Substantially Equivalent on 2002-04-05. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code KTI
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick,, MA, US
Recent devices under product code KTI
view allMore clearances from Boston Scientific Corp
view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
- K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)
- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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.