Company ยท US
Daig Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2000. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTB | Permanent Pacemaker Electrode | 28 |
| DYB | Introducer, Catheter | 18 |
| DQO | Catheter, Intravascular, Diagnostic | 4 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 |
| DTD | Pacemaker Lead Adaptor | 3 |
| LDF | Electrode, Pacemaker, Temporary | 3 |
| DQR | Cannula, Catheter | 1 |
| DRA | Catheter, Steerable | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 2000 | K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 Daig Corp. | DYB |
| May 15, 2000 | K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX Daig Corp. | DYB |
| Oct 19, 1998 | K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Sep 16, 1998 | K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER Daig Corp. | DYB |
| May 21, 1998 | K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER Daig Corp. | DYB |
| May 14, 1997 | K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER Daig Corp. | DYB |
| Feb 21, 1997 | K965249 | SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Oct 15, 1996 | K962805 | SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Nov 28, 1995 | K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS Daig Corp. | DYB |
| Mar 3, 1995 | K944284 | CONTROL Daig Corp. | DQO |
| Dec 27, 1994 | K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Daig Corp. | DRF |
| Nov 24, 1993 | K934285 | CATHETER INTRODUCER MODIFICATION Daig Corp. | DYB |
| Jan 26, 1993 | K913940 | RESPONSE(TM) STEERABLE CATHETER Daig Corp. | DRA |
| Jun 3, 1992 | K920779 | FAST-CATH HEMOSTASIS INTRODUCER Daig Corp. | DYB |
| Apr 16, 1992 | K920327 | DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER Daig Corp. | DYB |
| Mar 4, 1992 | K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN Daig Corp. | DRF |
| Jan 27, 1992 | K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. | LDF |
| Oct 28, 1991 | K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION Daig Corp. | DYB |
| May 7, 1991 | K910861 | PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK Daig Corp. | DYB |
| Jan 18, 1990 | K892528 | FIVE-YEAR STERILE PACKAGING SHELF LIFE Daig Corp. | DTB |
| Sep 26, 1989 | K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO Daig Corp. | DYB |
| Sep 18, 1989 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER Daig Corp. | DRF |
| Sep 12, 1989 | K894330 | DAIG VESSEL DILATOR Daig Corp. | DRE |
| Sep 6, 1989 | K894431 | MODIFIED LABELING TO PERMANENT LEAD INTRODUCER Daig Corp. | DYB |
| Aug 9, 1989 | K894430 | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY Daig Corp. | DYB |
| Jun 20, 1989 | K890794 | DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. | LDF |
| Apr 19, 1989 | K884697 | HEPARIN BONDING FOR CATHETERS Daig Corp. | DTB |
| Feb 22, 1989 | K884494 | DAIG OBTURATOR, CATHETER INTRODUCER Daig Corp. | DYB |
| Feb 22, 1989 | K884478 | DAIG COLLAPSIBLE STERILE SLEEVE Daig Corp. | DQR |
| Feb 12, 1988 | K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE Daig Corp. | LDF |
| Jan 29, 1988 | K874183 | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD Daig Corp. | DTB |
| Mar 18, 1987 | K870374 | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK Daig Corp. | DYB |
| Mar 3, 1987 | K870562 | DAIG PACEMAKER LEAD ADAPTOR Daig Corp. | DTD |
| Dec 5, 1986 | K864098 | TELECTRONICS SREW-IN/SLIM LINE PACING LEADS Daig Corp. | DTB |
| Nov 24, 1986 | K863921 | DAIG TYPE O4 VS-1 CONNECTOR Daig Corp. | DTB |
| May 9, 1983 | K830743 | POROUS TIP ENDOCARDIAL LEAD Daig Corp. | DTB |
| Mar 16, 1983 | K830464 | PACEMAKER ELECTRODE PERM. & TEMP Daig Corp. | DTB |
| Jan 16, 1981 | K802553 | PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN Daig Corp. | DTB |
| Jan 16, 1981 | K802552 | PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE Daig Corp. | DTB |
| Jan 16, 1981 | K802547 | PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. | DTB |
| Jun 30, 1980 | K800795 | PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. | DTB |
| May 30, 1980 | K800354 | LEAD, TINED PACING, IMPLANTABLE Daig Corp. | DTB |
| May 28, 1980 | K800356 | PERMANENT LEAD INTRADUCER Daig Corp. | DYB |
| May 28, 1980 | K800355 | LEAD, SUTURELESS MYOCARDIAL Daig Corp. | DTB |
| May 28, 1980 | K800353 | ADAPTER KIT Daig Corp. | DTD |
| May 28, 1980 | K800352 | PACEMAKER, ELECTRODE Daig Corp. | DTB |
| May 28, 1980 | K800351 | PACEMAKER, ELECTRODE, PERM. & TEMP. Daig Corp. | DTB |
| May 28, 1980 | K800350 | ENDOCARD. PACING LEAD STD. LENGTH PL202 Daig Corp. | DTB |
| May 28, 1980 | K800348 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR Daig Corp. | DTB |
| May 28, 1980 | K800347 | PERM. INPLANT ENDOCARD. PAC. LEAD Daig Corp. | DTB |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||