FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANALIZER HYDROPHILIC GUIDE WIRE
K Number: K050873
·
Decision May 26, 2005
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
46
Review Days
50
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
- CANALIZER HYDROPHILIC GUIDE WIRE
- K Number
- K050873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Device Technologies, Inc.
- Date Received
- April 6, 2005
- Decision Date
- May 26, 2005
- 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 Medical Device Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | Aug 27, 2010 | Substantially Equivalent |
| K053518 | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | Jan 26, 2006 | Substantially Equivalent |
| K051421 | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | Aug 30, 2005 | Substantially Equivalent |
| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | Feb 11, 2005 | Substantially Equivalent |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | Sep 30, 2004 | Substantially Equivalent |
| K040427 | FIBREX CATHETER PATENCY DEVICE | May 3, 2004 | Substantially Equivalent |
| K031442 | PBN GUIDEWIRES | Aug 13, 2003 | Substantially Equivalent |
| K021606 | EN-SNARE ENDOVASCULAR SNARE AND CATHETER | May 31, 2002 | Substantially Equivalent |
| K011790 | MICROCRUISER PLUS INTRODUCER SET | Sep 5, 2001 | Substantially Equivalent |
| K000620 | PBN FALLOPIAN TUBE CATHETER SYSTEM | Oct 30, 2000 | Substantially Equivalent |