Pathway Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Pathway Medical Technologies, Inc.” (first 2008, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 28 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 16 | 16 |
Review panels
- Cardiovascular (16)
Most recent Pathway Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120242 | JETSTREAM NAVITUS L SYSTEM | MCW | 2012-02-24 | 28 |
| K111229 | JETSTREAM G3 (R) SF 1.6 SYSTEM | MCW | 2011-06-01 | 30 |
| K110626 | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM | MCW | 2011-04-20 | 47 |
| K101334 | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON | MCW | 2010-06-11 | 30 |
| K101221 | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 | MCW | 2010-06-02 | 30 |
| K100462 | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 | MCW | 2010-05-19 | 90 |
| K093918 | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) | MCW | 2010-01-21 | 30 |
| K093456 | JETSTREAM G3 SYSTEM | MCW | 2009-12-01 | 26 |
| K092332 | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) | MCW | 2009-09-03 | 30 |
| K091509 | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | MCW | 2009-06-19 | 28 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pathway Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Pathway Medical Technologies, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00911417: A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System (Completed, started 2009-06)
- NCT00676494: The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions (Completed, started 2006-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pathway, LLC (3 510(k)s)
- Pathway Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pathway Medical Technologies, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Pathway Medical Technologies, Inc.” (first 2008, latest 2012), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pathway Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pathway Medical Technologies, Inc. is 30 days.
Which FDA product codes appear under Pathway Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 16).
Next steps
- See all 16 Pathway Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Pathway Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.