Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Daig Corp. — Predicate Candidate Screening

63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

89 daysmedian FDA review time
199 days90th percentile
63clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #40750Daig Corp.2000-11-293310
K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXDaig Corp.2000-05-151440
K982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETERDaig Corp.1998-10-191100
K982187FAST-CATH INTRA-CARDIAC INTRODUCERDaig Corp.1998-09-16862
K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDaig Corp.1998-05-212252
K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDaig Corp.1997-05-142014
K965249SPYGLASS ANGIOGRAPHIC CATHETERDaig Corp.1997-02-21710
K962805SPYGLASS ANGIOGRAPHIC CATHETERDaig Corp.1996-10-15890
K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDaig Corp.1995-11-28741
K944284CONTROLDaig Corp.1995-03-031820
K942379DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERDaig Corp.1994-12-272320
K934285CATHETER INTRODUCER MODIFICATIONDaig Corp.1993-11-24890
K913940RESPONSE(TM) STEERABLE CATHETERDaig Corp.1993-01-265110
K920779FAST-CATH HEMOSTASIS INTRODUCERDaig Corp.1992-06-031040
K920327DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCERDaig Corp.1992-04-16900
K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENDaig Corp.1992-03-041620
K914185PACEL(TM) FLOW DIRECTED PACING CATHETERDaig Corp.1992-01-271310
K914090DAIG FAST CATH(TM) INTRODUCER, MODIFICATIONDaig Corp.1991-10-28470
K910861PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCKDaig Corp.1991-05-07810
K892528FIVE-YEAR STERILE PACKAGING SHELF LIFEDaig Corp.1990-01-182820
K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODaig Corp.1989-09-26740
K894500DAIG ELECTROPHYSIOLOGY CATHETERDaig Corp.1989-09-18611
K894330DAIG VESSEL DILATORDaig Corp.1989-09-12600
K894431MODIFIED LABELING TO PERMANENT LEAD INTRODUCERDaig Corp.1989-09-06510
K894430MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAYDaig Corp.1989-08-09230
K890794DAIG PACEL(TM) FLOW DIRECTED PACING CATHETERDaig Corp.1989-06-201230
K884697HEPARIN BONDING FOR CATHETERSDaig Corp.1989-04-191610
K884494DAIG OBTURATOR, CATHETER INTRODUCERDaig Corp.1989-02-221201
K884478DAIG COLLAPSIBLE STERILE SLEEVEDaig Corp.1989-02-221200
K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODEDaig Corp.1988-02-12650
K874183ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEADDaig Corp.1988-01-291080
K870374PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCKDaig Corp.1987-03-18480
K870562DAIG PACEMAKER LEAD ADAPTORDaig Corp.1987-03-03212
K864098TELECTRONICS SREW-IN/SLIM LINE PACING LEADSDaig Corp.1986-12-05450
K863921DAIG TYPE O4 VS-1 CONNECTORDaig Corp.1986-11-24470
K830743POROUS TIP ENDOCARDIAL LEADDaig Corp.1983-05-09620
K830464PACEMAKER ELECTRODE PERM. & TEMPDaig Corp.1983-03-16290
K802553PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHANDaig Corp.1981-01-16930
K802552PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGEDaig Corp.1981-01-16930
K802547PERMANENT & TEMP. PACEMAKER ELECTRODEDaig Corp.1981-01-16930
K800795PERMANENT & TEMP. PACEMAKER ELECTRODEDaig Corp.1980-06-30820
K800354LEAD, TINED PACING, IMPLANTABLEDaig Corp.1980-05-301050
K800356PERMANENT LEAD INTRADUCERDaig Corp.1980-05-281030
K800350ENDOCARD. PACING LEAD STD. LENGTH PL202Daig Corp.1980-05-281030
K800351PACEMAKER, ELECTRODE, PERM. & TEMP.Daig Corp.1980-05-281030
K800348UNIPOLAR LEAD CONFIGURATION CONDUCTORDaig Corp.1980-05-281030
K800353ADAPTER KITDaig Corp.1980-05-281030
K800355LEAD, SUTURELESS MYOCARDIALDaig Corp.1980-05-281030
K800347PERM. INPLANT ENDOCARD. PAC. LEADDaig Corp.1980-05-281030
K800352PACEMAKER, ELECTRODEDaig Corp.1980-05-281030

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda