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FDA 510(k)

PPD BALLOON DILATATION CATHETER

K-Number: K020379 · 2002-05-06

ApplicantTelemed Systems, Inc.
Decision Date2002-05-06
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PPD BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 2002-05-06 under 510(k) number K020379. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PPD BALLOON DILATATION CATHETER?

PPD BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2002-05-06. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K020379.

When did PPD BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

PPD BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2002-05-06, under 510(k) number K020379.

Who is the listed applicant for PPD BALLOON DILATATION CATHETER?

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

What is the FDA product code for PPD BALLOON DILATATION CATHETER?

The FDA product code for PPD BALLOON DILATATION CATHETER is KNT.

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Other records listing Telemed Systems, 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.

K013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK010412FLEXIBLE ENDOSCOPIC SCISSORSK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSARK974300TELEMED SYSTEMS RETRIEVAL BASKET

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Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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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