FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K Number: K873675
·
Decision Oct 6, 1987
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
475
Review Days
22
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
- MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
- K Number
- K873675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Medtronic Vascular
- Date Received
- September 14, 1987
- Decision Date
- October 6, 1987
- Product Code
- GZB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZB), ordered by most recent decision date.
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation SCS system
FDA 510(k)
FDA Class 2
·Neurology
SandShark Injectable Anchor (SIA) System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Medtronic Vascular
| K Number | Device Name | ||
|---|---|---|---|
| K232570 | Steerant Super Stiff Guidewire | Oct 24, 2023 | Substantially Equivalent |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Aug 22, 2023 | Substantially Equivalent |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | Jun 30, 2023 | Substantially Equivalent |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | Apr 13, 2022 | Substantially Equivalent |
| K192296 | Medtronic 6F Taiga Guiding Catheter | Sep 20, 2019 | Substantially Equivalent |
| K173515 | Admiral Xtreme | Apr 12, 2018 | Substantially Equivalent |
| K162097 | InTRAkit | Nov 17, 2016 | Substantially Equivalent |
| K162027 | TRAcelet Compression Device | Oct 21, 2016 | Substantially Equivalent |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | Aug 19, 2016 | Unknown |
| K133539 | TOTAL ACROSS | Mar 26, 2014 | Substantially Equivalent |