Pathway Medical Technologies, Inc. FDA Record
Pathway Medical Technologies, Inc. has 0 FDA recalls, 0 inspections, 16 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pathway Medical Technologies, Inc." is on file.
- Latest 510(k)
- Feb 24, 2012
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 16 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K120242 | JETSTREAM NAVITUS L SYSTEM | Feb 24, 2012 |
| K111229 | JETSTREAM G3 (R) SF 1.6 SYSTEM | Jun 1, 2011 |
| K110626 | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM | Apr 20, 2011 |
| K101334 | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL… | Jun 11, 2010 |
| K101221 | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 | Jun 2, 2010 |
| K100462 | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 | May 19, 2010 |
| K093918 | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) | Jan 21, 2010 |
| K093456 | JETSTREAM G3 SYSTEM | Dec 1, 2009 |
| K092332 | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) | Sep 3, 2009 |
| K091509 | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | Jun 19, 2009 |
| K090325 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | Mar 11, 2009 |
| K083489 | JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 | Jan 23, 2009 |
| K083837 | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | Jan 13, 2009 |
| K082664 | JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 | Oct 6, 2008 |
| K082186 | MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM | Aug 29, 2008 |
| K081328 | PATHWAY PV ATHERECTOMY SYSTEM | Jul 17, 2008 |
Pathway Medical Technologies, Inc. and the FDA: common questions
Has Pathway Medical Technologies, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Pathway Medical Technologies, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Pathway Medical Technologies, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Pathway Medical Technologies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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