Innerdyne, Inc.
Salt Lake City, UT, US
Innerdyne, Inc. appears in FDA device records in Salt Lake City, UT. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Innerdyne, Inc. between 1995 and 2000. The busiest year on record is 1997, with 3. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992668 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) | DYB | Substantially Equivalent | |
| K990854 | INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE | FGE | Substantially Equivalent | |
| K990493 | INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE | GCJ | Substantially Equivalent | |
| K982417 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | GCJ | Substantially Equivalent | |
| K980578 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) | DYB | Substantially Equivalent | |
| K972684 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K971230 | SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT | KNT | Substantially Equivalent | |
| K970754 | INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP | GCJ | Substantially Equivalent | |
| K961940 | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP | GCJ | Substantially Equivalent | |
| K961430 | INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP | GCJ | Substantially Equivalent | |
| K950658 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP: | GCJ | Substantially Equivalent | |
| K950632 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | GCJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain