FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMSINO SUCTION CATHETER
K Number: K973199
·
Decision Sep 10, 1997
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
9
Review Days
15
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Basic Information
- Device Name
- AMSINO SUCTION CATHETER
- K Number
- K973199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amsino Intl., Inc.
- Date Received
- August 26, 1997
- Decision Date
- September 10, 1997
- Product Code
- BSY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Amsino Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070873 | AMSURE BLADDER IRRIGATION SET | Dec 19, 2007 | Substantially Equivalent |
| K992719 | AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE | Jan 12, 2000 | Substantially Equivalent |
| K974042 | AMSURE CLEANSING ENEMA SET | Dec 19, 1997 | Substantially Equivalent |
| K973107 | AMSINO I.V. ADMINISTRATION SET | Oct 2, 1997 | Substantially Equivalent |
| K971929 | AMSINO URINARY LEG BAG | Aug 6, 1997 | Substantially Equivalent |
| K964745 | AMSINO URINARY DRAINAGE BAG | Mar 18, 1997 | Substantially Equivalent |
| K950780 | AMSINO CERVICAL SCRAPER | Jul 25, 1995 | Substantially Equivalent |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | May 11, 1995 | Substantially Equivalent |