FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SNIPER ELITE MODEL-OR-E3872XX SERIES
K Number: K011905
·
Decision Aug 28, 2001
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
26
Review Days
70
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
- SNIPER ELITE MODEL-OR-E3872XX SERIES
- K Number
- K011905
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxxim Medical
- Date Received
- June 19, 2001
- Decision Date
- August 28, 2001
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQX), ordered by most recent decision date.
InQwire Amplatz Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
FDA 510(k)
FDA Class 2
·Cardiovascular
Enroute 0.014'' Transcarotid Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
EmeryGlide (EG18008901)
FDA 510(k)
FDA Class 2
·Cardiovascular
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
FDA 510(k)
FDA Class 2
·Cardiovascular
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Maxxim Medical
| K Number | Device Name | ||
|---|---|---|---|
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Nov 12, 2002 | Substantially Equivalent |
| K021452 | STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE | Aug 1, 2002 | Substantially Equivalent |
| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | May 31, 2001 | Substantially Equivalent |
| K010297 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) | Feb 16, 2001 | Substantially Equivalent |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Oct 19, 2000 | Substantially Equivalent |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Dec 21, 1999 | Substantially Equivalent |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | Jul 15, 1999 | Substantially Equivalent |
| K984189 | ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER | May 5, 1999 | Substantially Equivalent |