FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DYNAREX SUCTION CATHETERS & KITS
K Number: K922843
·
Decision Jan 11, 1993
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
19
Review Days
213
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Basic Information
- Device Name
- DYNAREX SUCTION CATHETERS & KITS
- K Number
- K922843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dynarex Corp.
- Date Received
- June 12, 1992
- Decision Date
- January 11, 1993
- 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 Dynarex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 | Dec 22, 2005 | Substantially Equivalent |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Nov 9, 2005 | Substantially Equivalent |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | Oct 17, 2002 | Substantially Equivalent |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Mar 6, 2002 | Substantially Equivalent |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Nov 28, 2001 | Substantially Equivalent |
| K991695 | DYNAREX NON-WOVEN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K991694 | DYNAREX DRAIN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dec 11, 1998 | Substantially Equivalent |
| K960388 | DYNAREX NON-WOVEN SPONGE | Apr 1, 1996 | Substantially Equivalent |
| K951660 | DYNAREX GAUZE SPONGE | May 9, 1995 | Substantially Equivalent |