FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
K Number: K083784
·
Decision Mar 30, 2009
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
103
Review Days
101
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Basic Information
- Device Name
- PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
- K Number
- K083784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- December 19, 2008
- Decision Date
- March 30, 2009
- Product Code
- QEZ
- 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 |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Vascular Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182232 | Octane Mechanical Thrombectomy System | Sep 11, 2018 | Substantially Equivalent |
| K181647 | Bandit guidewire | Jul 20, 2018 | Substantially Equivalent |
| K180913 | VSI Micro-Introducer Kit | May 9, 2018 | Substantially Equivalent |
| K180088 | TrapLiner catheter | Apr 4, 2018 | Substantially Equivalent |
| K180128 | Warrior 14 guidewire | Feb 16, 2018 | Substantially Equivalent |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume | Jan 19, 2018 | Substantially Equivalent |
| K173532 | Raider Guidewire | Dec 15, 2017 | Substantially Equivalent |
| K173266 | Octane aspiration system | Dec 1, 2017 | Substantially Equivalent |
| K170544 | Langston dual lumen catheter | Nov 17, 2017 | Substantially Equivalent |
| K171946 | Gel-Bead | Oct 25, 2017 | Substantially Equivalent |