FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
HEMO-STREAM HEMODIALYSIS CATHETER SET
K Number: K023847
·
Decision Apr 30, 2003
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
13
Review Days
162
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Basic Information
- Device Name
- HEMO-STREAM HEMODIALYSIS CATHETER SET
- K Number
- K023847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Rex Medical
- Date Received
- November 19, 2002
- Decision Date
- April 30, 2003
- Product Code
- MSD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Rex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Jun 1, 2012 | Substantially Equivalent |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | May 22, 2012 | Substantially Equivalent |
| K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER | Nov 18, 2010 | Substantially Equivalent |
| K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | Feb 18, 2010 | Substantially Equivalent |
| K081410 | OPTION VENA CAVA FILTER | Jun 4, 2009 | Substantially Equivalent |
| K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | Aug 22, 2007 | Unknown |
| K051468 | INNER-LOCK INTRODUCER SHEATH | Aug 4, 2005 | Substantially Equivalent |
| K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | Feb 26, 2004 | Substantially Equivalent |
| K033793 | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM | Dec 16, 2003 | Substantially Equivalent |
| K032569 | SHORT INTRODUCER SHEATH | Sep 16, 2003 | Substantially Equivalent |