FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PBN GUIDEWIRES
K Number: K031442
·
Decision Aug 13, 2003
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
46
Review Days
99
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Basic Information
- Device Name
- PBN GUIDEWIRES
- K Number
- K031442
- 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
- May 6, 2003
- Decision Date
- August 13, 2003
- 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 |
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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 |
| K050873 | CANALIZER HYDROPHILIC GUIDE WIRE | May 26, 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 |
| 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 |