Company ยท US
Norton Performance Plastics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1985. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 4 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 |
| FMG | Stopcock, I.V. Set | 4 |
| DQY | Catheter, Percutaneous | 3 |
| FPA | Set, Administration, Intravascular | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| DYG | Catheter, Flow Directed | 2 |
| GAZ | Tubing, Noninvasive | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| FID | Tubing, Dialysate | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
| KRA | Catheter, Continuous Flush | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 1985 | K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 Norton Performance Plastics Corp. | DTR |
| Sep 25, 1985 | K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION Norton Performance Plastics Corp. | DQY |
| May 7, 1985 | K851299 | CORRECT FLO Norton Performance Plastics Corp. | FPA |
| Sep 11, 1984 | K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 Norton Performance Plastics Corp. | FPA |
| Jul 13, 1984 | K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD Norton Performance Plastics Corp. | DQY |
| Apr 17, 1984 | K840240 | MICROFUSE INTRAVENOUS CATHETER SET Norton Performance Plastics Corp. | DQY |
| Oct 19, 1983 | K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER Norton Performance Plastics Corp. | LJS |
| Aug 11, 1983 | K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 Norton Performance Plastics Corp. | DRS |
| Apr 30, 1983 | K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- Norton Performance Plastics Corp. | DQO |
| Apr 28, 1983 | K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER Norton Performance Plastics Corp. | DYB |
| Apr 14, 1983 | K830969 | PERM. REPAIR KIT FOR LEONARD NORTON DUAL Norton Performance Plastics Corp. | LJS |
| Jul 30, 1982 | K821996 | LEONARD PERIPHERAL VENOUS PRESSURE CATH Norton Performance Plastics Corp. | DYG |
| Jul 2, 1982 | K821679 | LEONARD/NORTON HYPERALIMENTATION CATHET. Norton Performance Plastics Corp. | FOZ |
| Apr 15, 1982 | K820864 | NORTON MANIFOLD Norton Performance Plastics Corp. | DTL |
| Apr 1, 1982 | K820710 | NEONATAL INTRODUCER KIT Norton Performance Plastics Corp. | DYB |
| Mar 25, 1982 | K820677 | TOUCH FLUSH CONTINUOUS FAST/FLUSH Norton Performance Plastics Corp. | DRS |
| Mar 25, 1982 | K820676 | TOUCH FLUSH W/Y TRANSDUCER CONNECTOR Norton Performance Plastics Corp. | DRS |
| Mar 18, 1982 | K820581 | NORTON JUGULAR KITS Norton Performance Plastics Corp. | DYB |
| Feb 12, 1982 | K820229 | NORTON FLOW DIRECTED THERMODILUTION CATH Norton Performance Plastics Corp. | DYG |
| Dec 2, 1981 | K813137 | CORREC TORR TM Norton Performance Plastics Corp. | DRS |
| Dec 19, 1980 | K802945 | PRESSURE MONITORING SET Norton Performance Plastics Corp. | DQO |
| Apr 29, 1980 | K800622 | EXTENSION LINE Norton Performance Plastics Corp. | DQO |
| Apr 24, 1980 | K800621 | PERCUTANEOUS CATHETER INTRODUCER ADAPTER Norton Performance Plastics Corp. | DYB |
| Apr 24, 1980 | K800620 | VENOUS M/A INTERNAL JUGULAR KIT Norton Performance Plastics Corp. | DYB |
| Apr 24, 1980 | K800619 | THERMODILUTION CATHETER INTRO. KIT Norton Performance Plastics Corp. | DYB |
| Apr 24, 1980 | K800618 | SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET Norton Performance Plastics Corp. | DQO |
| Feb 6, 1980 | K791512 | CONTINUOUS AMBULATORY DIALYSIS (CAPD) Norton Performance Plastics Corp. | KDJ |
| Dec 13, 1979 | K791890 | CONTINUOUS FLUSH DEVICE, CAT. #14-370 Norton Performance Plastics Corp. | KRA |
| Jun 22, 1979 | K791107 | STOPCOCK, THREE WAY Norton Performance Plastics Corp. | DTL |
| May 4, 1979 | K790604 | CUSTOM TUBING SETS Norton Performance Plastics Corp. | FPA |
| Mar 21, 1979 | K790358 | FLUID ADMINISTRATION CAT.#14-923 Norton Performance Plastics Corp. | GAZ |
| Jul 27, 1978 | K780985 | PVC LINES FOR MONITORING Norton Performance Plastics Corp. | GAZ |
| Jul 17, 1978 | K780984 | PVC QUICK PRIME LINES Norton Performance Plastics Corp. | KRI |
| Jun 6, 1978 | K780662 | SUPPLEMENTAL TYGON PAC-MONITORING LINES Norton Performance Plastics Corp. | FMG |
| Aug 22, 1977 | K771387 | MONITORING LINES & FLUID ADMIN. Norton Performance Plastics Corp. | FPK |
| Jun 17, 1977 | K770916 | TYGON PAC-MONITORING LINES & FLUID ADMIN Norton Performance Plastics Corp. | FMG |
| Jun 8, 1977 | K770708 | TYGON PAC-STOPCOCKS Norton Performance Plastics Corp. | FMG |
| Jun 3, 1977 | K770707 | TYGON PAC-MONITORING LINES & FLUID ADMIN Norton Performance Plastics Corp. | FMG |
| Mar 16, 1977 | K770299 | TYGON M-60/TYGON M-70 Norton Performance Plastics Corp. | FID |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||