FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TITANIUM CONNECTOR (2 PART)
K Number: K910787
·
Decision Aug 15, 1991
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
15
Applicant Total
9
Review Days
171
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Basic Information
- Device Name
- TITANIUM CONNECTOR (2 PART)
- K Number
- K910787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Accurate Surgical Instruments Co.
- Date Received
- February 25, 1991
- Decision Date
- August 15, 1991
- Product Code
- FKO
- 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 |
|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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MODIFIED USE OF PULL-APART INTRODUCER SET
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Other Clearances by Accurate Surgical Instruments Co.
| K Number | Device Name | ||
|---|---|---|---|
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Dec 15, 1995 | Substantially Equivalent |
| K920515 | INSERTION | May 4, 1992 | Substantially Equivalent |
| K910786 | TROCAR (FALLER STYLET) | Sep 19, 1991 | Substantially Equivalent |
| K910785 | TITANIUM CATHETER EXTENDER | Aug 22, 1991 | Substantially Equivalent |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Jun 19, 1986 | Substantially Equivalent |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Jul 26, 1985 | Substantially Equivalent |
| K813488 | CATHETER REGULAR | Dec 31, 1981 | Substantially Equivalent |
| K813487 | CATHETER BUBBLE STAND | Dec 31, 1981 | Substantially Equivalent |