FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bard Snare Retrieval Kit
K Number: K152560
·
Decision Oct 23, 2015
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
31
Applicant Total
21
Review Days
44
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
- Bard Snare Retrieval Kit
- K Number
- K152560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neometrics, Inc.
- Date Received
- September 9, 2015
- Decision Date
- October 23, 2015
- Product Code
- MMX
- 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 |
|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMX), ordered by most recent decision date.
LimFlow V-Ceiver
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatz Goose Neck Snare Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Gunther Tulip Vena Cava Filter Retrieval Set
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow V-Ceiver
FDA 510(k)
FDA Class 2
·Cardiovascular
ONO Retrieval Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Neometrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150225 | NovaGold High Performance Guidewire | Mar 16, 2015 | Substantially Equivalent |
| K143135 | Spring Coil Guidewire | Feb 20, 2015 | Substantially Equivalent |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | Feb 20, 2014 | Substantially Equivalent |
| K123439 | NEO ERCP GUIDEWIRE | Jan 3, 2013 | Substantially Equivalent |
| K101729 | NEOWIRE PTA/PTCA GUIDEWIRE | Sep 23, 2010 | Substantially Equivalent |
| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | Feb 15, 2007 | Substantially Equivalent |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | Mar 1, 2005 | Substantially Equivalent |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | Apr 19, 2004 | Substantially Equivalent |
| K033321 | SELECTIVA SB GUIDEWIRE | Nov 5, 2003 | Substantially Equivalent |
| K031652 | VASCUPUNCTURE PICC GUIDEWIRE | Sep 30, 2003 | Substantially Equivalent |