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FDA 510(k)

TightRail Sub-C Rotating Dilator Sheath

K-Number: K161333 · 2016-07-08

ApplicantSpectranetics, Inc.
Decision Date2016-07-08
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TightRail Sub-C Rotating Dilator Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K161333. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TightRail Sub-C Rotating Dilator Sheath?

TightRail Sub-C Rotating Dilator Sheath is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Spectranetics, Inc.. The 510(k) number is K161333.

When did TightRail Sub-C Rotating Dilator Sheath receive FDA 510(k) clearance?

TightRail Sub-C Rotating Dilator Sheath received FDA 510(k) clearance on 2016-07-08, under 510(k) number K161333.

Who is the listed applicant for TightRail Sub-C Rotating Dilator Sheath?

The FDA 510(k) record lists Spectranetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TightRail Sub-C Rotating Dilator Sheath?

The FDA product code for TightRail Sub-C Rotating Dilator Sheath is DRE.

Other records listing Spectranetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P910001DEVICE, ANGIOPLASTY, LASER, CORONARYPMA P050018Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoringK250385Turbo-Elite Laser Atherectomy CatheterK223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersK212784TightRail Guardian Motorized Dilator Sheath

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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