FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K Number: K033333
·
Decision Nov 14, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
- K Number
- K033333
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aomori Olympus Co., Ltd.
- Date Received
- October 16, 2003
- Decision Date
- November 14, 2003
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Aomori Olympus Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K042160 | SONOSURG TROCAR | Jan 25, 2005 | Substantially Equivalent |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | Sep 8, 2004 | Substantially Equivalent |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Oct 1, 2003 | Substantially Equivalent |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aug 29, 2003 | Substantially Equivalent |
| K021672 | PANCREATIC DRAINAGE TUBE | Apr 16, 2003 | Substantially Equivalent |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | Mar 28, 2003 | Substantially Equivalent |