Martech Medical Products
Harleysville, PA, US
MARTECH MEDICAL PRODUCTS appears in FDA device records in Harleysville, PA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Martech Medical Products between 1989 and 2013. The busiest year on record is 1993, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 3 |
| 1996 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130855 | PTFE SUPER SHEATH INTRODUCER | DYB | Substantially Equivalent | |
| K120617 | PTFE SUPER SHEATH INTRODUCER | DYB | Substantially Equivalent | |
| K101399 | COAXIAL INTRODUCER SET | DYB | Substantially Equivalent | |
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | FBK | Substantially Equivalent | |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | JKA | Substantially Equivalent | |
| K922438 | PRO2 OXYGEN ANALYZER | CCL | Substantially Equivalent | |
| K926007 | ACCESSORY TO PISTON SYRINGE | FMF | Substantially Equivalent | |
| K914778 | NEOLINE(TM) | CBT | Unknown | |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | JKA | Substantially Equivalent | |
| K890473 | NEEDLE GUARD(TM) | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2527072 | 2527072 | MARTECH MEDICAL PRODUCTS | 1500 DELP DR., HARLEYSVILLE, PA 19438 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CBTArterial Blood Sampling Kit
- LFKCatheter, Femoral
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FJSCatheter, Peritoneal, Long-Term Indwelling
- LFJCatheter, Subclavian
- DREDilator, Vessel, For Percutaneous Catheterization
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- DYBIntroducer, Catheter
- FMINeedle, Hypodermic, Single Lumen
- FADStent, Ureteral
- BZTStethoscope, Esophageal, With Electrical Conductors
- FMFSyringe, Piston
- KGCTube, Gastro-Enterostomy
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain