Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scimed Life Systems, Inc. — Predicate Candidate Screening
109 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
197 days90th percentile
109clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | Scimed Life Systems, Inc. | 1998-11-12 | 365 | 0 |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1998-08-18 | 90 | 2 |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | Scimed Life Systems, Inc. | 1998-04-29 | 90 | 0 |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Scimed Life Systems, Inc. | 1998-02-23 | 80 | 1 |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1998-02-19 | 65 | 3 |
| K973945 | LUGE GUIDE WIRE | Scimed Life Systems, Inc. | 1998-01-12 | 88 | 0 |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1997-06-03 | 89 | 2 |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPP | Scimed Life Systems, Inc. | 1997-05-21 | 189 | 0 |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | Scimed Life Systems, Inc. | 1997-03-28 | 65 | 0 |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUI | Scimed Life Systems, Inc. | 1997-03-04 | 78 | 0 |
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Scimed Life Systems, Inc. | 1997-02-10 | 68 | 3 |
| K962572 | SCIMED CHOICE PT VISION PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1996-12-17 | 169 | 3 |
| K961294 | SCIMED DISPATCH GOLD CORONARY CATHETER | Scimed Life Systems, Inc. | 1996-07-03 | 90 | 0 |
| K961015 | SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE | Scimed Life Systems, Inc. | 1996-05-15 | 63 | 0 |
| K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F | Scimed Life Systems, Inc. | 1996-05-15 | 42 | 0 |
| K960563 | SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES | Scimed Life Systems, Inc. | 1996-04-29 | 80 | 0 |
| K960657 | SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER | Scimed Life Systems, Inc. | 1996-04-29 | 73 | 1 |
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE | Scimed Life Systems, Inc. | 1996-03-22 | 87 | 0 |
| K953133 | SCIMED DISPATCH CORONARY INFUSION CATHETER | Scimed Life Systems, Inc. | 1996-02-23 | 232 | 0 |
| K953265 | SCIMED ANGIOGRAPHIC KITS | Scimed Life Systems, Inc. | 1996-01-16 | 187 | 0 |
| K953515 | SCIMED TRIGUIDE GUIDE CATHETERS | Scimed Life Systems, Inc. | 1995-09-19 | 55 | 0 |
| K952872 | SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER | Scimed Life Systems, Inc. | 1995-07-27 | 78 | 0 |
| K951802 | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT | Scimed Life Systems, Inc. | 1995-07-21 | 93 | 0 |
| K951720 | SCIMED EXPO ANGIOGRAPHIC CATHETER | Scimed Life Systems, Inc. | 1995-06-22 | 69 | 0 |
| K950216 | SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-06-22 | 154 | 0 |
| K951089 | SCIMED GATEWAY PLUS | Scimed Life Systems, Inc. | 1995-05-31 | 83 | 0 |
| K950835 | SCIMED CHOICE PT PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-05-25 | 90 | 0 |
| K950534 | SCIMED SCEPTOR PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-04-28 | 80 | 0 |
| K950535 | SCIMED SCEPTOR EXCHANGE GUIDE WIRE | Scimed Life Systems, Inc. | 1995-04-28 | 80 | 0 |
| K950266 | SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-04-14 | 81 | 0 |
| K950731 | SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER | Scimed Life Systems, Inc. | 1995-04-05 | 48 | 0 |
| K950141 | SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-03-31 | 77 | 0 |
| K950113 | SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-03-31 | 79 | 0 |
| K946240 | SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-03-31 | 99 | 0 |
| K946180 | SCIMED(R) ENTRE PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-03-17 | 87 | 0 |
| K946204 | SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS | Scimed Life Systems, Inc. | 1995-03-13 | 82 | 0 |
| K945129 | SCIMED CHIOCE PLUS PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1995-03-03 | 135 | 0 |
| K950094 | SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER | Scimed Life Systems, Inc. | 1995-03-03 | 52 | 0 |
| K945593 | SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER | Scimed Life Systems, Inc. | 1995-01-13 | 60 | 0 |
| K945159 | SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1994-12-30 | 70 | 0 |
| K943192 | SCIMED CHOICE(TM) PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1994-11-22 | 140 | 0 |
| K944815 | SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CAT | Scimed Life Systems, Inc. | 1994-11-14 | 46 | 0 |
| K944537 | SCIMED TRIGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1994-10-21 | 36 | 0 |
| K943777 | SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER | Scimed Life Systems, Inc. | 1994-10-13 | 72 | 0 |
| K943783 | 7 FRENCH LARGE LUMEN TRIGUIDE-PLUS | Scimed Life Systems, Inc. | 1994-10-13 | 71 | 0 |
| K942333 | SCIMED EN TRE' III PTCA GUIDE WIRE | Scimed Life Systems, Inc. | 1994-08-31 | 107 | 0 |
| K931335 | SCIMED(R) VENTURE(TM) INFUSION CATHETER | Scimed Life Systems, Inc. | 1994-07-27 | 498 | 0 |
| K941137 | SCIMED TRIGUIDE GUIDING CATHETER | Scimed Life Systems, Inc. | 1994-06-22 | 104 | 0 |
| K941895 | SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING | Scimed Life Systems, Inc. | 1994-05-24 | 36 | 0 |
| K934541 | SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION | Scimed Life Systems, Inc. | 1994-05-12 | 238 | 1 |
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