FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K Number: K881873
·
Decision May 18, 1988
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
39
Review Days
15
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Basic Information
- Device Name
- INTRODUCTION/DRAINAGE CATHETER & ACCESS
- K Number
- K881873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sheridan Catheter Corp.
- Date Received
- May 3, 1988
- Decision Date
- May 18, 1988
- Product Code
- GBS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Sheridan Catheter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922894 | LAZER-TRACH TRACHEAL TUBE | May 7, 1993 | Substantially Equivalent |
| K897046 | LASER RESISTANT TRACHEAL TUBE | Mar 23, 1990 | Substantially Equivalent |
| K890823 | ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER | May 5, 1989 | Substantially Equivalent |
| K884765 | CLINICAL ELECTRONIC THERMOMETERS | Feb 16, 1989 | Substantially Equivalent |
| K882918 | KIM NASO-INTESTINAL TUBE | Dec 5, 1988 | Substantially Equivalent |
| K882127 | CLINICAL ELECTRONIC THERMOMETERS | Aug 4, 1988 | Substantially Equivalent |
| K881368 | CLINICAL ELECTONIC THERMOMETERS | Jul 13, 1988 | Substantially Equivalent |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | Jun 16, 1988 | Substantially Equivalent |
| K880960 | NDYAG LASER TRACHEAL TUBE | Apr 29, 1988 | Substantially Equivalent |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Jan 19, 1988 | Substantially Equivalent |