FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEADWAY 17 ADVANCED MICROCATHETER
K Number: K101542
·
Decision Aug 6, 2010
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
85
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEADWAY 17 ADVANCED MICROCATHETER
- K Number
- K101542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroVention, Inc.
- Date Received
- June 3, 2010
- Decision Date
- August 6, 2010
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by MicroVention, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232542 | Wedge XL Delivery Catheter | May 16, 2024 | Substantially Equivalent |
| K230775 | SOFIA EX Intracranial Support Catheter | Sep 14, 2023 | Substantially Equivalent |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | Apr 27, 2023 | Substantially Equivalent |
| K222115 | ISAAC Neurovascular Navigation Catheter | Jan 10, 2023 | Substantially Equivalent |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | Dec 21, 2022 | Substantially Equivalent |
| K214024 | SOFIA 88 Catheter | Sep 12, 2022 | Substantially Equivalent |
| K211120 | ERIC Retrieval Device | Mar 31, 2022 | Substantially Equivalent |
| K193607 | BOBBY Balloon Guide Catheter | Jul 21, 2020 | Substantially Equivalent |
| K201487 | Traxcess 7 Mini Guidewire | Jul 2, 2020 | Substantially Equivalent |
| K200547 | Traxcess 14 SELECT Guidewire | Apr 16, 2020 | Substantially Equivalent |