MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM— 510(k) K082186
Substantially EquivalentPathway Medical Technologies, Inc.
FDA 510(k) clearance K082186 for MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM, Substantially Equivalent on 2008-08-29. Applicant: Pathway Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Pathway Medical Technologies, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kirkland, WA, US
Recent devices under product code MCW
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view all- K120242 — JETSTREAM NAVITUS L SYSTEM
- K111229 — JETSTREAM G3 (R) SF 1.6 SYSTEM
- K110626 — JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
- K101334 — JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
- K101221 — JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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.