Daig Corp.
Minnetonka, MN, US
Daig Corp. appears in FDA device records in Minnetonka, MN. FDA records list 35 510(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
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Daig Corp. between 1986 and 2000. The busiest year on record is 1989, with 9. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 9 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 | DYB | Substantially Equivalent | |
| K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | DYB | Substantially Equivalent | |
| K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER | DYB | Substantially Equivalent | |
| K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER | DYB | Substantially Equivalent | |
| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | DYB | Substantially Equivalent | |
| K965249 | SPYGLASS ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K962805 | SPYGLASS ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | DYB | Substantially Equivalent | |
| K944284 | CONTROL | DQO | Substantially Equivalent | |
| K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | |
| K934285 | CATHETER INTRODUCER MODIFICATION | DYB | Substantially Equivalent | |
| K913940 | RESPONSE(TM) STEERABLE CATHETER | DRA | Substantially Equivalent | |
| K920779 | FAST-CATH HEMOSTASIS INTRODUCER | DYB | Substantially Equivalent | |
| K920327 | DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER | DYB | Substantially Equivalent | |
| K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN | DRF | Substantially Equivalent | |
| K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER | LDF | Substantially Equivalent | |
| K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION | DYB | Substantially Equivalent | |
| K910861 | PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK | DYB | Substantially Equivalent | |
| K892528 | FIVE-YEAR STERILE PACKAGING SHELF LIFE | DTB | Substantially Equivalent | |
| K894343 | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO | DYB | Substantially Equivalent | |
| K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | |
| K894330 | DAIG VESSEL DILATOR | DRE | Substantially Equivalent | |
| K894431 | MODIFIED LABELING TO PERMANENT LEAD INTRODUCER | DYB | Substantially Equivalent | |
| K894430 | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY | DYB | Substantially Equivalent | |
| K890794 | DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER | LDF | Substantially Equivalent | |
| K884697 | HEPARIN BONDING FOR CATHETERS | DTB | Substantially Equivalent | |
| K884494 | DAIG OBTURATOR, CATHETER INTRODUCER | DYB | Substantially Equivalent | |
| K884478 | DAIG COLLAPSIBLE STERILE SLEEVE | DQR | Substantially Equivalent | |
| K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE | LDF | Substantially Equivalent | |
| K874183 | ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD | DTB | Substantially Equivalent | |
| K870374 | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK | DYB | Substantially Equivalent | |
| K870562 | DAIG PACEMAKER LEAD ADAPTOR | DTD | Substantially Equivalent | |
| K864098 | TELECTRONICS SREW-IN/SLIM LINE PACING LEADS | DTB | Substantially Equivalent | |
| K863921 | DAIG TYPE O4 VS-1 CONNECTOR | DTB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DQRCannula, Catheter
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQOCatheter, Intravascular, Diagnostic
- DRACatheter, Steerable
- DREDilator, Vessel, For Percutaneous Catheterization
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
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