Medcomp
Harleysville, PA, US
Medcomp appears in FDA device records in Harleysville, PA. FDA records list 40 510(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
- 40
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 40 510(k) clearances for Medcomp between 1982 and 2014. The busiest year on record is 2002, with 6. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 2 |
| 1983 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 6 |
| 2010 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130889 | SPLIT CATH RG | MSD | Unknown | |
| K123292 | T3 | NIE | Substantially Equivalent | |
| K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | LJS | Substantially Equivalent | |
| K091954 | MICRO-STICK SET | DYB | Substantially Equivalent | |
| K092347 | PRO-PICC CT | LJS | Substantially Equivalent | |
| K091953 | PRO-PICC | LJS | Substantially Equivalent | |
| K090394 | VALVED TEARWAY INTRODUCER | DYB | Substantially Equivalent | |
| K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | LJS | Substantially Equivalent | |
| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | LJS | Substantially Equivalent | |
| K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | DQX | Substantially Equivalent | |
| K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) | LJS | Substantially Equivalent | |
| K080544 | UNASSIGNED | FPA | Substantially Equivalent | |
| K072509 | PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAY | LJS | Substantially Equivalent | |
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) | LJT | Substantially Equivalent | |
| K061986 | 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 | LJS | Substantially Equivalent | |
| K053092 | MEDCOMP VASCU-SHEATH II | DYB | Substantially Equivalent | |
| K053345 | PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D | LJS | Substantially Equivalent | |
| K051280 | MEDCOMP SPLIT CATH II | MSD | Substantially Equivalent | |
| K040318 | MEDCOMP SPLIT-CATH II | MSD | Substantially Equivalent | |
| K040328 | 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER | MSD | Substantially Equivalent | |
| K033570 | MEDCOMP T-3 | NIE | Substantially Equivalent | |
| K040992 | 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 | MSD | Unknown | |
| K030502 | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 | MSD | Substantially Equivalent | |
| K030270 | 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON | LJS | Substantially Equivalent | |
| K022678 | MEDCOMP SC4 | MSD | Unknown | |
| K022570 | MEDCOMP REPAIR KIT, MODEL ASPCRPK | NFK | Substantially Equivalent | |
| K022513 | MEDCOMP VASCU-SHEATH INTRODUCER SET | DYB | Substantially Equivalent | |
| K020936 | 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL | MSD | Unknown | |
| K021759 | 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 | MSD | Unknown | |
| K020315 | 14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL | MSD | Unknown | |
| K020465 | MEDCOMP ASH SPLIT-CATH II | MSD | Substantially Equivalent | |
| K013162 | 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH | KNT | Substantially Equivalent | |
| K010306 | MEDCOMP EXCELL SPLIT TIP CATHETER | MSD | Substantially Equivalent | |
| K003110 | MEDCOMP BIO-CATH CATHETER LINE | LJS | Substantially Equivalent | |
| K972207 | MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM | MSD | Substantially Equivalent | |
| K971281 | RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE | DQX | Substantially Equivalent | |
| K953811 | MEDCOMP P-CATH | FOZ | Substantially Equivalent | |
| K830438 | MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM | LFJ | Substantially Equivalent | |
| K821955 | MCSCK638 CATHETER IN A TRAY (KIT) | LFJ | Substantially Equivalent | |
| K821954 | MCSCK838 CATHETER IN A TRAY (KIT) | LFJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MSDCatheter, Hemodialysis, Implanted
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LFJCatheter, Subclavian
- DYBIntroducer, Catheter
- NFKKit, Repair, Catheter, Hemodialysis
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FPASet, Administration, Intravascular
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
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