510(k) K971395
- Device
- GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
- Applicant
- TARGET THERAPEUTICS
- 510(k) number
- K971395
- Product code
- DQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-14
- Date received
- 1997-04-15
- Regulation
- 870.1330
- Classification name
- Wire, Guide, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROXANE K BAXTER
- Address
- 47201 Lakeview Dr. Freemont CA US 94538 94538
FDA Registration Numbers#
- 9616088
- 1016427
- 3020968442
- 3014579161
- 3005941719
- 3009380063
- 1000121056
- 3013611763
- 3002808486
- 3036802499
- 3014279513
- 3007830707
- 2134812
- 3010432890
- 3012223769
- 3006950086
- 3006283319
- 3011564431
- 3015489752
- 3011137372
- 3014590708
- 3002917664
- 3007138831
- 3012536737
- 3012931345
- 3007635982
- 1721686
- 3012159165
- 1417485
- 3003084417
- 3013666336
- 2024168
- 3000126629
- 1319639
- 3004748528
- 1644312
- 9610849
- 3012154226
- 8010026
- 2183870
- 3010882065
- 3035642068
- 3009546466
- 3042175841
- 3009756153
- 3007064586
- 3010155661
- 2134285
- 1721676
- 3039642752
- 3009600098
- 3009121749
- 1721504
- 2183744
- 3013162291
- 1724474
- 2184149
- 1928237
- 1319211
- 2024311
- 3014461810
- 3016119728
- 3013556777
- 3027260597
- 3011642792
- 3012497308
- 1222301
- 3004365956
- 1649395
- 3009526575
- 3008061490
- 1820334
- 2134244
- 3008264254
- 3010532612
- 3026317086
- 3006946276
- 3010419931
- 9681834
Source Documents#
Other 510(k) Records For Product Code DQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260168 | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) | Skycade Med Corporation | 2026-10-16 |
| K253146 | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | 2026-09-18 |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | 2026-09-03 |
| K253667 | Accoat Guide Wire | Sp Medical A/S | 2026-07-14 |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | 2026-07-13 |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | 2026-05-22 |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | 2026-03-20 |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | 2026-03-19 |
| K253262 | EmeryGlide™ (EG18008901) | Nano4imaging GmbH | 2026-03-06 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | 2026-01-31 |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | 2026-01-21 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026-01-09 |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2025-11-09 |
| K250203 | SureAx-Guide™ | Sureax Medical, LLC | 2025-10-17 |
| K250031 | Amplatzer Guidewire | ABBOTT MEDICAL | 2025-10-03 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases