FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
K Number: K082664
·
Decision Oct 6, 2008
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
16
Review Days
24
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Basic Information
- Device Name
- JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
- K Number
- K082664
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pathway Medical Technologies, Inc.
- Date Received
- September 12, 2008
- Decision Date
- October 6, 2008
- Product Code
- MCW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Pathway Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120242 | JETSTREAM NAVITUS L SYSTEM | Feb 24, 2012 | Substantially Equivalent |
| K111229 | JETSTREAM G3 (R) SF 1.6 SYSTEM | Jun 1, 2011 | Substantially Equivalent |
| K110626 | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM | Apr 20, 2011 | Substantially Equivalent |
| K101334 | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON | Jun 11, 2010 | Substantially Equivalent |
| K101221 | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 | Jun 2, 2010 | Substantially Equivalent |
| K100462 | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 | May 19, 2010 | Substantially Equivalent |
| K093918 | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) | Jan 21, 2010 | Substantially Equivalent |
| K093456 | JETSTREAM G3 SYSTEM | Dec 1, 2009 | Substantially Equivalent |
| K092332 | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) | Sep 3, 2009 | Substantially Equivalent |
| K091509 | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | Jun 19, 2009 | Substantially Equivalent |