FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
K Number: K073092
·
Decision Jan 29, 2008
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
16
Review Days
89
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Basic Information
- Device Name
- DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
- K Number
- K073092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spire Biomedical, Inc.
- Date Received
- November 1, 2007
- Decision Date
- January 29, 2008
- 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 Spire Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073093 | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, | Jan 22, 2008 | Substantially Equivalent |
| K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 | Feb 12, 2007 | Substantially Equivalent |
| K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 | Jan 29, 2007 | Substantially Equivalent |
| K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | Dec 5, 2006 | Substantially Equivalent |
| K060288 | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS | Sep 1, 2006 | Unknown |
| K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | May 9, 2006 | Substantially Equivalent |
| K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS | Dec 3, 2004 | Substantially Equivalent |
| K041559 | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 | Jul 30, 2004 | Unknown |
| K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 | Apr 19, 2004 | Substantially Equivalent |
| K032061 | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH | Dec 23, 2003 | Unknown |