FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PBN FALLOPIAN TUBE CATHETER SYSTEM
K Number: K000620
·
Decision Oct 30, 2000
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
46
Review Days
249
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Basic Information
- Device Name
- PBN FALLOPIAN TUBE CATHETER SYSTEM
- K Number
- K000620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Device Technologies, Inc.
- Date Received
- February 24, 2000
- Decision Date
- October 30, 2000
- Product Code
- MDG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MDG | System, Intrafallopian Cannula | FDA class 2 | Obstetrics/Gynecology |
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 |
| 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 |