AMPLATZER SIZING BALLOON— 510(k) K993248
Substantially EquivalentAga Medical Corp.
FDA 510(k) clearance K993248 for AMPLATZER SIZING BALLOON, Substantially Equivalent on 2000-07-12. Applicant: Aga Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Aga Medical Corp.
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code MJN
view allMore clearances from Aga Medical Corp.
view all- K113658 — AMPLATZER VASCULAR PLUG 4
- K093476 — AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
- K091793 — AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
- K083214 — AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
- K080994 — AMPLATZER TORQVUE EXCHANGE SYSTEM
Adverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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.