510(k) · Cleared
ClearedSelector Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 11, 1998 as substantially equivalent to K960801 (North American Instrument Corp., 1996) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 11, 1998
- Review
- 60 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922552 (1993). 5 ancestors in all, the oldest K921310 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922552 | Morse (R) Angiographic Catheters | North American Instrument Corp. | 1993 | — |
| −1 | K960801 | Selector Angiographic Catheter (Various Models) | North American Instrument Corp. | 1996 | — |
| 0 (this device) | K982077 | Selector Diagnostic Catheter | Boston Scientific Scimed, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K925522 | FDA’s K925522 is Centrysystem 3 with Charts/BP Option Our OCR of the scanned summary read K925522, FDA’s number for Centrysystem 3 with Charts/BP Option (C.G.H. Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “5 French and 6 French SELECTOR™ diagnostic catheters”. Kept off the family tree. Summary page 1…00 Janell A. Colley Regulatory Affairs Specialist 4 French SELECTOR™ diagnostic catheter Class II 5 French and 6 French SELECTOR™ diagnostic catheters (March 3, 1993: K925522/March 29, 1996: K960801) 4 French SUPER TORQUE and SUPERTORQUEPLUS™ diagnostic catheter (April 2, 1996: K960975). The 4 French… | 1994 |
| * | K960801 | Selector Angiographic Catheter (Various Models)Summary page 1…ulatory Affairs Specialist 4 French SELECTOR™ diagnostic catheter Class II 5 French and 6 French SELECTOR™ diagnostic catheters (March 3, 1993: K925522/March 29, 1996: K960801) 4 French SUPER TORQUE and SUPERTORQUEPLUS™ diagnostic catheter (April 2, 1996: K960975). The 4 French SELECTOR" diagnostic cat… | 1996 |
| * | K960975 | 1-4F Infiniti Angiographic CatheterSummary page 1…6 French SELECTOR™ diagnostic catheters (March 3, 1993: K925522/March 29, 1996: K960801) 4 French SUPER TORQUE and SUPERTORQUEPLUS™ diagnostic catheter (April 2, 1996: K960975). The 4 French SELECTOR" diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982077: Selector Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982077
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026