Therex Corp.
Walpole, MA, US
Therex Corp. appears in FDA device records in Walpole, MA. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Therex Corp. between 1988 and 1995. The busiest year on record is 1994, with 9. The most recent is 1995, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 9 |
| 1995 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953110 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | LJT | Substantially Equivalent | |
| K953017 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | LJT | Substantially Equivalent | |
| K952537 | THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. | LJT | Substantially Equivalent | |
| K950212 | A2 DETACHED DUAL PORT SYSTEM | LJT | Substantially Equivalent | |
| K950131 | 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL | LJT | Substantially Equivalent | |
| K942412 | THEREX LOW-PROFILE PORT - TITANIUM MODEL | LJT | Substantially Equivalent | |
| K936012 | THEREX LOW PROFILE PORT-TITANIUM MODEL | LJT | Substantially Equivalent | |
| K934802 | THEREX LOW-PROFILE PORT-TITANIUM | LJT | Substantially Equivalent | |
| K934792 | THEREX LOW-PROFILE PORT | LJT | Substantially Equivalent | |
| K933350 | THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM | LJT | Unknown | |
| K933316 | THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM | LJT | Unknown | |
| K932447 | THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D. | LJT | Substantially Equivalent | |
| K932671 | THEREX R-PORT | LJT | Unknown | |
| K936029 | NON-CORNING (HUBER) NEEDLE | FMI | Substantially Equivalent | |
| K925373 | THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D | LJT | Substantially Equivalent | |
| K926011 | A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI | LJT | Substantially Equivalent | |
| K922434 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT | LJT | Substantially Equivalent | |
| K921379 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT | LJT | Substantially Equivalent | |
| K921475 | A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM | LJT | Substantially Equivalent | |
| K911055 | A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT | LJT | Substantially Equivalent | |
| K903691 | A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX. | LJT | Substantially Equivalent | |
| K902166 | WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K896093 | A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT | LJT | Substantially Equivalent | |
| K893460 | A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM | LJT | Substantially Equivalent | |
| K882230 | A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED | LJT | Substantially Equivalent | |
| K875214 | A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | 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