FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K Number: K932218
·
Decision Aug 27, 1993
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
29
Review Days
112
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Basic Information
- Device Name
- CARDIAC CATH OR ANGIOGRAPHIC TRAYS
- K Number
- K932218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Associated Medical Products Co.
- Date Received
- May 7, 1993
- Decision Date
- August 27, 1993
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Associated Medical Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Mar 19, 1997 | Substantially Equivalent |
| K932216 | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | Apr 19, 1994 | Unknown |
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Feb 22, 1994 | Substantially Equivalent |
| K932217 | MAJOR, MINOR, BASIN TRAYS (PACKS) | Nov 15, 1993 | Unknown |
| K932220 | LAP CHOLY TRAYS (PACKS) | Sep 27, 1993 | Unknown |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Jul 9, 1993 | Unknown |
| K842983 | AMPCO OPTHALMIC TRAY | May 22, 1985 | Substantially Equivalent |
| K843114 | AMPCO PROCEDURE TRAYS / PACKS | Aug 8, 1984 | Unknown |
| K823839 | AMPCO KIDNEY DIALYSIS TRAY | Mar 29, 1983 | Substantially Equivalent |
| K821579 | SKIN SCRUB-TRAY | Jul 21, 1982 | Substantially Equivalent |