JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON— 510(k) K101334
Substantially EquivalentPathway Medical Technologies, Inc.
FDA 510(k) clearance K101334 for JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON, Substantially Equivalent on 2010-06-11. 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
view allMore clearances from Pathway Medical Technologies, Inc.
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
- K101221 — JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
- K100462 — JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, 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.