Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Target Therapeutics — Predicate Candidate Screening
70 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
333 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | Target Therapeutics | 1998-04-21 | 488 | 0 |
| K964488 | DETACHABLE SILICONE BALLOON (DSB) | Target Therapeutics | 1998-04-21 | 529 | 0 |
| K964210 | RETRIEVER II | Target Therapeutics | 1997-10-31 | 374 | 0 |
| K971395 | GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 | Target Therapeutics | 1997-07-14 | 90 | 0 |
| K965189 | SPINNAKER | Target Therapeutics | 1997-03-24 | 90 | 0 |
| K964112 | BERENSTEIN COIL | Target Therapeutics | 1997-02-26 | 134 | 0 |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | Target Therapeutics | 1996-12-17 | 117 | 0 |
| K962503 | GUGLIELMI DETACHABLE COIL | Target Therapeutics | 1996-09-20 | 85 | 0 |
| K961923 | BERENSTEIN COIL | Target Therapeutics | 1996-08-15 | 90 | 0 |
| K960705 | GUGLIELMI DETACHABLE COIL | Target Therapeutics | 1996-05-21 | 90 | 0 |
| K960806 | TURBO TRACKER | Target Therapeutics | 1996-05-02 | 64 | 0 |
| K955293 | FIBERED PLATINUM COIL, .035 TYPE | Target Therapeutics | 1996-02-06 | 82 | 2 |
| K951159 | FASGUIDE | Target Therapeutics | 1995-09-25 | 195 | 0 |
| K951256 | DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) | Target Therapeutics | 1995-09-08 | 171 | 0 |
| K950069 | DASHER-14 | Target Therapeutics | 1995-04-12 | 93 | 0 |
| K935597 | FASGUIDE CATHETER | Target Therapeutics | 1994-10-18 | 333 | 0 |
| K925813 | DIAGNOSTIC INTRAVASCULAR CATHETER | Target Therapeutics | 1994-03-23 | 491 | 0 |
| K926243 | ANGIOGRAPHIC CATHETER | Target Therapeutics | 1993-08-16 | 248 | 0 |
| K921247 | ZEPHYR INFUSION CATHETER | Target Therapeutics | 1993-06-29 | 470 | 0 |
| K925632 | BALT GUIDING CATHETER | Target Therapeutics | 1993-06-29 | 232 | 0 |
| K925633 | BALT INTRODUCER | Target Therapeutics | 1993-06-25 | 228 | 0 |
| K930961 | CATHETER GUIDEWIRE (PERIPHERAL USE) | Target Therapeutics | 1993-05-26 | 91 | 0 |
| K923368 | MAGIC INFUSION CATHETER | Target Therapeutics | 1993-04-07 | 272 | 0 |
| K921649 | RETRIEVER 10 | Target Therapeutics | 1993-03-11 | 339 | 0 |
| K924987 | TAPER GUIDEWIRES | Target Therapeutics | 1992-12-08 | 55 | 0 |
| K922912 | SEEKER LITE - 10 | Target Therapeutics | 1992-11-17 | 153 | 0 |
| K915895 | STEALTH DILATION CATHETER SYSTEM (MODIFIED) | Target Therapeutics | 1992-06-04 | 323 | 0 |
| K914786 | TARGET THERAPEUTICS COILS | Target Therapeutics | 1992-04-20 | 180 | 0 |
| K915521 | TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED | Target Therapeutics | 1992-03-23 | 144 | 0 |
| K915115 | GUIDER DASHER | Target Therapeutics | 1992-02-14 | 93 | 0 |
| K915114 | GUIDE WIRE EXTENSION | Target Therapeutics | 1992-02-11 | 90 | 0 |
| K914031 | GUIDER-22 | Target Therapeutics | 1992-02-11 | 154 | 0 |
| K914032 | NITINOL SEEKER(R) GUIDE WIRES | Target Therapeutics | 1992-02-11 | 154 | 0 |
| K914030 | GUIDER, DASHER | Target Therapeutics | 1992-02-11 | 154 | 0 |
| K914067 | RETRIEVAL DEVICE | Target Therapeutics | 1991-12-10 | 90 | 0 |
| K912293 | REMOVE LABELING RESTRICT FROM GUIDE WIRES | Target Therapeutics | 1991-12-05 | 196 | 0 |
| K914001 | TARGET THERAPEUTICS RADIOPAQUE STYLET | Target Therapeutics | 1991-11-22 | 77 | 0 |
| K913312 | HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED | Target Therapeutics | 1991-11-08 | 106 | 0 |
| K911779 | HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED | Target Therapeutics | 1991-11-08 | 210 | 0 |
| K911605 | TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES | Target Therapeutics | 1991-07-09 | 90 | 0 |
| K911560 | ZEPHYR INFUSION CATHETER | Target Therapeutics | 1991-07-05 | 88 | 0 |
| K911089 | STEALTH CATHETER SYSTEM | Target Therapeutics | 1991-05-29 | 85 | 0 |
| K904287 | STEALTH DILATION CATHETER SYSTEM/MODIFICATION | Target Therapeutics | 1991-01-16 | 124 | 0 |
| K901721 | MODIFIED TARGET THERAPEUTICS COILS | Target Therapeutics | 1990-07-03 | 81 | 0 |
| K894105 | TARGET THERAPEUTICS TRACKER LF CATHETER | Target Therapeutics | 1989-09-28 | 111 | 0 |
| K891688 | COIL AND COIL DELIVERY SYSTEM | Target Therapeutics | 1989-09-22 | 184 | 0 |
| K893411 | STEALTH DILATION CATHETER SYSTEM | Target Therapeutics | 1989-09-05 | 126 | 0 |
| K894084 | TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE | Target Therapeutics | 1989-08-17 | 70 | 0 |
| K884198 | TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE | Target Therapeutics | 1988-12-13 | 68 | 0 |
| K880762 | TAPER FLEX-TIP STEERABLE GUIDEWIRE | Target Therapeutics | 1988-08-19 | 176 | 0 |
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